elpro on-and off-site-service beschreibung · 2019. 7. 5. · warehouses, from risk analysis ......

ELPRO | Service Description On- und Off-Site Service

SD_EL_ELPRO_On-und Off-Site-Service_V9E.docx | / 26

ELPRO Service Description: On- and Off-Site Service

Specifications Service description of ELPROs on- and Off-Site services, including calibration methods,

measurement uncertainties, and calibration tolerances.

Document valid from 08.Aug.2020

Release notification Based on release notification of 08.May.2020

Document release

Product Management Quality

Name Philipp Osl Steven Turner

Date 08.May.2020 08.May.2020

Signature Due to the Covid19 situation 2020 / absence from location

(home office) N.N1. has checked the document and

confirms the release by email on the above date

Version history

Version Date Author Description

V1E 17.Jul.2015 S. Blakolmer Initial Version; translated from German version V2D.

V2E 29.Sep.2015 S. Blakolmer The calibration tolerances for temperature and humidity are

recalculated. Additionally to the system accuracy, the uncertainty of

measurement with k=1 is added to include the influence of the

measurement process.

All other measurement variables are added in the next version.

V3E 08.Feb.2016 S. Blakolmer Not released

V4E 08.Feb.2016 S. Blakolmer Off-Site Service added, complete revision

3: Closer definition of System Accuracy and Calibration Tolerance

4: Measurement Uncertainty summarised as table

5: Calibration Tolerances completed and rounding error corrected

8: Only one signature left on Factory Calibration Certificate

Translated from German version V4D

V5E 28.Nov.2016 S. Blakolmer editorial changes

1: AGENT D NTx, PTx, HTx removed, GxP Services added

2: In-Process Humidity: Calibration range changed.

4: New tolerances added for CO2-Transmitter GMP251, ECOLOG-NET

LA8 with PT100-Transmitter and LIBERO CD. ECOLOG-NET LR8 with

RTH and LIBERO THi1 tolerances split into new devices and

recalibration.

V6E 29.Jun.2017 S. Blakolmer Changes according to change request CN_17_022.

Extension for new products: LIBERO W and ECOLOG-PRO



V7E 28.May.2018 S. Blakolmer Range of LIBERO W extended to -35 °C. ECOLOG-PRO 2TH added.

HAMSTER-A AT1 and HOTDOG DT1 removed, service discontinued.

Novasina transmitter: Included drift figures provided by Novasina.

2.2: Humidity generator and In-Process Calibration Humidity:

calibration range changed to +10 °C..+40 °C

V8E 03.Jul.2019 S. Blakolmer Merged all subsidiaries into one document.

2: Deleted HOTBOX SE, service no longer available.

2: ECOLOG-NET LH2 production stopped but service still available.

2: Added new devices ECOLOG-PRO 2TH.

3: Standard calibration points harmonized within all branches.

Removed device tolerances and added standard tolerances based on

process requirements of WHO guideline TS961 Annex 9.

Conversion of the reference removed e.g. for humidity generator.

3.1: Ice-water calibration valid without reference device.

3.3: Deleted electrical calibration for Schischek and E+E-

Transmitters.

4: Added risk analysis for temperature and humidity probe.

4.4: Updated uncertainties to harmonized values.

5/6: Updated certificate examples to currently available template.

V9E 08.May.2020 B. Niggemann

S. Blakolmer

S. Turner

1.4: Added chapter about alarm testing.

1.7: Removed table of devices available

2: HOTBOX HTH, HTN deleted, ECOLOG-NET LH2, ECOLOG-NET LA8,

ECOLOG-NET LP4 service until mid 2025. Added new devices

ECOLOG-PRO RBR + 1NTR, LIBERO CE

3.1: Standard tolerances for LN2 updated to ± 2.0 °C. Calibration

bath CH only available up to +70 °C.

3.3: Added missing devices.

3.4: Tolerances for in wc changed.

3.4/4.5: Unit in wc changed to in H2O.

4.4: Added chapter about calibration intervals.

4.5: Updated figures to current uncertainty budgets.



Content ELPRO Service Description: On- and Off-Site Service ............................................................................................. 1

Document release ................................................................................................................................................. 1

Version history ...................................................................................................................................................... 1

Content ................................................................................................................................................................. 3

1. ELPRO Services ........................................................................................................................................... 4

1.1. GxP Service .................................................................................................................................................. 4

1.2. Installations / Qualifications ........................................................................................................................ 4

1.3. Check-up / Maintenance ............................................................................................................................. 4

1.4. Alarm Testing (optional) .............................................................................................................................. 5

1.5. Data Back-up................................................................................................................................................ 5

1.6. Calibration and Accreditation ...................................................................................................................... 5

1.7. Continuous Monitoring ............................................................................................................................... 7

1.8. Data Recovery .............................................................................................................................................. 7

1.9. Repairs ......................................................................................................................................................... 7

1.10. Disposal of devices .................................................................................................................................. 8

2. Device Overview......................................................................................................................................... 8

3. Service Description Calibration ................................................................................................................... 9

3.1. Temperature Calibration ............................................................................................................................. 9

3.2. Combined Temperature- / Humidity Calibration ...................................................................................... 11

3.3. Electrical Calibration .................................................................................................................................. 13

3.4. Differential Pressure Calibration ............................................................................................................... 14

3.5. CO2 - Calibration ........................................................................................................................................ 14

3.6. O2 - Calibration .......................................................................................................................................... 15

3.7. Air Velocity ................................................................................................................................................ 15

3.8. Particle Counter ......................................................................................................................................... 15

4. Analysing Calibration Results ....................................................................................................................16

4.1. Conformity Statement ............................................................................................................................... 16

4.2. Risk Assessment and Drift of Temperature Probes ................................................................................... 17

4.3. Risk Assessment and Drift of Humidity Probes ......................................................................................... 18

4.4. Defining Calibration Intervals .................................................................................................................... 19

4.5. Comparison of ISO 17025, ILAC and International Accreditation Bodies .................................................. 20

4.6. Measurement Uncertainty ........................................................................................................................ 22

5. Example ISO 17025 Calibration Certificate (SCS 0122) ..............................................................................23

6. Example ISO 17025 Calibration Certificate (ANAB L2357) ..........................................................................24

7. Example Factory Calibration Certificate ....................................................................................................25



1. ELPRO Services

ELPRO distinguishes between services provided at the customer site (On-Site Service) and

services provided at one of the ELPRO service locations (Off-Site Services). Both are

performed by qualified service technicians.

An On-Site service includes the installation, qualification, calibration, and maintenance of

ELPRO installations and devices. Products in need of maintenance, repair, or calibration are

sent to an ELPRO branch for an Off-Site service.

1.1. GxP Service

The execution of GxP projects is supported by an experienced team of GxP engineers.

ELPRO offers an all-around package for the entire qualification of pharmaceutical

warehouses, from risk analysis of the current storage process to different phases of

qualification from DQ to OQ until the qualification report. The ELPRO qualification service is

built modular and contains the following modules:

General GMP / GDP conformity analysis

Risk assessment

Support with issuing of validation or qualification plans and reports

Temperature and humidity mapping and stress testing

1.2. Installations / Qualifications

On-site installations of hardware and software, including the relevant qualification, are

performed by service technicians. The services required for each installation or qualification

is specified by an order or a project. ELPRO provides GMP conforming documentation for

the qualification and performs the qualification On-Site.

1.3. Check-up / Maintenance

A check-up is done on each device to assess functionality.

The check-up includes:

Visual inspection of casing, interfaces (DB15, Lemo, RH, USB, etc.), battery

compartment, and the available accessories (mountings, sensors, ...)

Clean-up, if necessary (decontamination is performed by the customer)

Check-up of programming and readout functionality

Check-up of keyboard and display functionality

Plausibility check of external channels and internal sensors

(either by an electrical check or during the calibration)

Determination of the age of the device in order to find relevant firmware-updates

Replacement of internal battery, if necessary

Additional tests to assess UPS (uninterrupted power supply) can be ordered optionally.



1.4. Alarm Testing (optional)

For On-Site installation, ELPRO offers optional alarm testing during maintenance and

calibration service. During alarm testing, the physical environmental conditions are changed

to provoke an alarm on the system. The technician then will check if the alarm is displayed in

the software, alarm forwarding to email is working correctly, and any additional accessories

are working correctly (e.g. alarm light / horn or automatic telephone dialer).

As a result, ELPRO provides GMP-conform documentation for the performed alarm testing.

1.5. Data Back-up

For CMS-installations with elproSUITE, data are saved by the On-Site service team to the

autosave-folder prior to the calibration.

For CMS-installations with elproMONITOR, data are stored in a database. A back-up prior to

calibration is not required.

The backup of AMS- and CCMS-devices if performed by the customer prior to the

calibration. Optionally, this can also be performed by ELPRO (separate order required).

1.6. Calibration and Accreditation

A calibration measurement compares a unit under test to a traceable reference value. The

accuracy of the unit under test will be documented with a calibration certificate (examples

available at the end of the document).

Standardised calibration processes are used for calibrations. Specific calibrations, requested

by the customer, that deviate from the standard in the process and methods, the used

references as well as the content of the certificates, are defined in a project.

The international standard for calibration is ISO 17025. It covers all requirements for the

quality management system and all technical requirements to ensure competency in

calibration and testing.

ILAC is the international organization for laboratory accreditation bodies and its purpose is

to harmonize and recognize local accreditations. Therefore, all signatories of the mutual

recognition agreement of ILAC are evaluated and deemed to be equal.

ELPRO-BUCHS AG is an officially accredited calibration laboratory for Off-Site and On-Site

calibrations (at customer site). The Swiss Accreditation Service SAS accreditation number is

“SCS 0122” per the ISO 17025 standard for ELPRO-BUCHS AG.

Accredited calibrations are available from our laboratories for Off-Site calibration in

Switzerland and Germany. Non-accredited calibrations are also available at the laboratory

ELPRO Benelux B.V.

On-Site Calibration performed in signatory countries of the European co-operation for

Accreditation (EA) by ELPRO technicians is supervised under the laboratory of ELPRO-BUCHS

AG. This service is available from our branches in Switzerland, Germany, United Kingdom

and Netherlands.



ELPRO Services Inc. is an officially accredited calibration laboratory for Off-Site and On-Site

calibrations. The ANSI National Accreditation Board (ANAB) accreditation number is “L2357”

per the ISO 17025 standard for ELPRO Services. ELPRO Services Inc. provides accredited

calibration services in the United States of America and Canada.

Additional security measures are taken for ISO 17025 calibrations, including approved

number of measurement values of the reference unit and the unit under test,

documentation of environmental conditions and testing of reference equipment prior to the

calibration. The calibration processes, measurement uncertainties, and the competence of

the employees are continuously verified by the accreditation authority.

A simplified process is used for factory calibration.

Measurement Off-Site On-Site

CH DE NL US CH DE US UK NL DK SG

Temperature 1 1 2 1 1 2 1 1 1

Temp. / relative humidity 1 1 2 1 1 1 1 1

Electrical calibration 2 2

Differential pressure 1 - 2 1 2 - - - -

CO2 - 2 2 - - - -

O2 - - - - - - - - -

Air velocity - - - - - - - - -

Particle counter - - - - 3 3 - - - - - 1 Accredited according to ISO 17025 (SCS 0122), details see SAS accreditation scope. 2 Accredited according to ISO 17025 (ANAB L2357), details see ANAB accreditation scope.

3 Factory Calibration done by an external partner.

On-site calibration services outside of the location of ELPRO branches may be limited due to

country specific regulations or transportation issues (e.g. travelling with a gas cylinder).

Calibration in Ex zones: ELPRO does not have Ex-protected calibration equipment. However,

it is possible to either provide a solution with replacement sensors, or customer-specific

measures such as repeal the Ex zone.



1.7. Continuous Monitoring

ELPRO can provide temporary replacement data loggers for customers that require

continuous monitoring during the calibration and maintenance process. Devices with

external or internal sensors are available.

ELPRO has a pool of calibrated temporary replacement devices. These can be configured

(according to customer specifications) and installed to the measuring point by the On-Site

service team, prior to the calibration.

The data on the replacement device will be analysed. The data and calibration certificate are

handed over to the customer after the completion of the calibration.

Calibrated rental devices are also available as replacement of devices that are sent to an

ELPRO branch for Off-Site servicing. Rental devices are to be ordered prior to the planned

calibration. Continuous monitoring is ensured by the replacement of the sent-in device.

The following devices and probes are available as temporary replacement devices:

Temporary replacement data

logger for On-Site services

- LIBERO Te1-P/THi1 (interval ≥ 5 min)

- LIBERO CE/CH (interval ≥ 5 min)

Rental devices for Off-Site services - ECOLOG TNx, TPx, TH1

1.8. Data Recovery

A data recovery can be performed in addition to the check-up if requested by the customer.

All methods available at ELPRO are used for the data recovery in order to save and analyse

data that is still stored on the data logger (for example what type of data was found, if the

time stamp is plausible, which data are reliable or not). After a successful data recovery, the

customer will receive the data in a PDF-report (and if possible also the embedded data).

1.9. Repairs

A successful repair fixes all detected errors of a product - the product guarantee is extended

for another six months.

ELPRO offers the following repair services:

ECOLOG Repair of display, keyboard, quartz, RH-socket, Lemo-connector

ECOLOG-NET Repair is not possible

ECOLOG-PRO Repair is not possible

LIBERO Tx, Cx, Wx Repair is not possible

Sensor cable repair

The cables of devices with sensor cables are checked and

shortened if broken (if the length of the cable is sufficient). The

functionality of the probe is then tested in ice water.



1.10. Disposal of devices

No longer functioning devices or devices beyond repair are disposed or recycled by ELPRO.

ELPRO advocates for a respectful treatment of the environment for present and future

generations. All devices beyond repair can of course also be sent back to the customer.

2. Device Overview

Device Group Type

Off-Site

On-Site

CH DE US NL CH DE US UK NL DK SG

Central monitoring

systems (CMS)

ECOLOG-NET LP4*

ECOLOG-NET LH2*

ECOLOG-NET LA8*/LR8 + T / RH

ECOLOG-NET LA8*/LR8 + Δp - - - - -

ECOLOG-NET LA8*/LR8 + CO2 - - - - -

ECOLOG-NET LA8*/LR8 + O2 - - - - - - - - -

ECOLOG-NET LA8*/LR8 + flow - - - - - - - - -

ECOLOG-PRO RBR + 1NTR

ECOLOG-PRO 4PT

ECOLOG-PRO 2TH

ECOLOG-PRO 4MA + T / RH

ECOLOG-PRO 4MA + Δp - - - - -

ECOLOG-PRO 4MA + CO2 - - - - -

ECOLOG-PRO 4MA + O2 - - - - - - - - -

ECOLOG-PRO 4MA + flow - - - - - - - - -

Autonomous

monitoring systems

(AMS)

ECOLOG TNx (internal probe) - 1 1 1 1 1 1 1

ECOLOG TNx, TPx, THx (external

probe)

LIBERO Te1-Nx, Te1-Ux, Te1-Px

LIBERO Ti1x - 1 1 1 1 1 1 1

LIBERO THi1

LIBERO CE -

LIBERO W ?

HAMSTER ET1, ET1-D, EHT1 - 1 1 1 1 1 1 1

HAMSTER-E ET2 -

HOTBOX HTH, HTN (until end of 2019) - - - - - - - -

Cold chain

monitoring systems

(CCMS)

LIBERO Cx - - - - - - - - - -

LIBERO ITS - - - - - - - - - - -

Third party device (that does not require additional software)

1 For devices with internal probes, calibration recommended at 0 °C in ice-water, additional points as in-process calibration or in humidity generator.

* Until mid of 2025



3. Service Description Calibration

ELPRO uses only qualified and calibrated equipment for calibrations. The technicians perform the calibration

according to internal work instructions and checklists.

The calibration certificate is issued after the successful calibration and handed over to the customer. ELPRO

recommends using the standard calibration points and tolerances specified in chapters 3.1 to 3.8. Specific

calibration points and tolerances are possible, but may take longer to complete.

3.1. Temperature Calibration

Standard calibration points for temperature calibrations:

Area of Application 1 point 2 points 3 points

Cryo storage -196 °C -196 °C -196 °C, 0 °C -196 °C, -85 °, 0 °C

Ultra frozen -80 °C -80 °C -85 °C, 0 °C -85 °C, -30 °C, 0 °C

Frozen below -15 °C -25 °C -30 °C, 0 °C -30 °C, -15 °C, 0 °C

Refrigerator +2 °C..+8 °C 4 °C or 5 °C 0 °C, +10 °C 0 °C, +5 °C, +10 °C

Cool +8 °C..+15 °C

+20 °C 0 °C, +40 °C 0 °C, +20 °C, +40 °C Room temperature +15 °C..+25 °C

Incubator +37 °C

Standard tolerances, used if customer tolerances are not available or the customer agrees

to the standard tolerances:

dry block, bath

Dry Block Calibrator - LAB_Block, OS_Block

Range of use: -90 °C..+125 °C (CH/US: available up to +150 °C)

A qualified and calibrated dry block calibrator is used for the calibration. The internal

probe of the dry block calibrator is used as a reference for factory calibrations. Precise,

traceable and calibrated reference thermometers are used to increase reliability of

reference values for ISO 17025 calibrations. The unit under test probe is immersed in the

dry block to a minimum depth of 90mm.

Environmental conditions during On-Site calibration: 0 °C..+40 °C; 0% RH..90% RH (non-condensing)

Environmental conditions during Off-Site calibration: +18 °C..+28 °C; 0% RH..90% RH (non-condensing)

Calibration Bath - LAB_Bath (only available as Off-Site service)

Range of use CH/DE: -40 °C..+70 °C

Range of use US: -80 °C..+90 °C

Expanded Range 3: LN2 -196 °C and > 150 °C

± 2.0 °C

Expanded Range 2:

-100 °C..-31 °C and +31 °C..+150 °C dry block, bath

or calibration using humidity generator / in-process

± 1.0 °C

Core Range 1: -30 °C..+30 °C

dry block, bath, ice-water

± 0.5 °C

based on WHO 961, Annex 9



For a factory calibration the unit under test is placed in a calibration bath and compared to

a precise, traceably calibrated reference thermometer.

For ISO 17025 calibrations data of the reference and the unit under test are recorded over

a period. The unit under test probe is immersed in a calibration bath to a minimum depth

of 15 times the probe diameter.

Environmental conditions during Off-Site calibration: +18 °C..+28° C; 0% RH..90% RH (non-condensing)

Ice-Water: Fix-Temperature 0°C - LAB_Ice, OS_Ice

The calibration medium, a predefined ice-water mixture, corresponds to the triple point of

water. If micro-cube ice (max. 10x10x10 mm) or crushed ice (max. 30x20x10 mm) is

available, the rated value is 0.00 °C. Otherwise as additional safety, the unit under test is

compared to a precise, traceable calibrated reference thermometer. The unit under test

probe is immersed in an ice-water to a minimum depth of 15 times the probe diameter.



Liquid Nitrogen: Fixed temperature -196 °C - LAB_LN2, OS_LN2

Liquid nitrogen is used as calibration medium; the unit under test is compared with a

precise, traceable and calibrated reference thermometer. The unit under test probe is

immersed in liquid nitrogen to a minimum depth of 100mm or 15 times the probe

diameter.



In-Process Comparison - OS_InProcess

Range of use: -196 °C..+150 °C

An in-process calibration is mainly used if it is technically impossible to remove the probe

for a calibration.

Therefore a one-point measurement is performed during the process (e.g.in a Freezer).

The precise, traceable and calibrated reference thermometer is placed as close as possible

to the unit under test and the reference value is recorded over a defined period of time.

Environmental conditions: 0 °C..+50 °C; 0% RH..90% RH (non-condensing)

Dry Ice /Alcohol: Fixed temperature -78°C - LAB_DIA, OS_DIA

The calibration medium is a predefined Dry Ice-Alcohol mixture. The unit under test and

the precise, traceable calibrated reference thermometer are compared in the calibration

medium. The unit under test probe is immersed in a Dry Ice-Alcohol mixture to a minimum

depth of 15 times the probe diameter.





3.2. Combined Temperature- / Humidity Calibration

Standard calibration points for the combined temperature- / humidity calibration:

Area of Application 1 point 2 points 3 calibration points

Room temperature

+15 °C to +25 °C

+23 °C 0 °C*, +23 °C 0 °C*, +23 °C, +30 °C*

50% RH

@ +23 °C

35% RH, 80% RH

@ +23 °C

35% RH, 50% RH, 80% RH

@ +23 °C

*Calibrations with reference solutions are done at +23°C. All other temperatures are calibrated using methods

described in chapter 3.1.

Standard tolerances, used if customer tolerances are not available or the customer agrees

to the standard tolerances: Temperature tolerances are found in chapter 3.1.

Capacitive: Electrolytic: ECOLOG-PRO 2TH CSS, LIBERO THi1, ECOLOG THx, ECOLOG-PRO 2TH ENS

ECOLOG-NET LR8 + RTHx, ECOLOG-NET LH2, HAMSTER external sensors Vaisala

external sensors E+E/Schischek

Humidity Generator

Range of use: 10% RH..90% at +10°C..+40°C

A qualified humidity generator with external reference probes is used for the combined

temperature- / humidity calibration. For ISO 17025 calibrations, additional reference values

from precise, traceable and calibrated reference probes. The unit under test probe is placed

in an environmental chamber inside an isothermal block to a minimum depth of 20mm.

Standard-Calibration (LAB_HGS, OS_HGS):

The standard calibration ensures the quick and reliable measuring of up to 4 combined

temperature-/humidity probes at the same time. All probes are, with an extension cable,

connected to the data logger, summarised and calibrated together.

Calibration with electrical line test (OS_HGSE):

It is optional to electronically calibrate the data logger incl. original wiring (see chapter 3.3)

Calibration with original wiring (LAB_HGSYS, OS_HGSYS):

For a calibration with original wiring each probe is measured separately at the installation

site. Additional time is required for this kind of calibration because of the often exposed

installation sites and the distance to the data logger.

Environmental conditions during On-Site calibration: +10 °C..+35 °C; 0% RH..90% RH (clean, dust-free, draft-free,

no chemicals, no dew, no condensation)

As Found

± 5.0% RH

deviation >5%

replacement

As Left

± 4.0% RH

typical drift

ca. 1% / year

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t

As Found

± 3.5% RH

deviation >3.5%

replacement

As Left

± 2.5% RH

typical drift

ca. 1% / year

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Environmental conditions during Off-Site calibration: +20 °C..+26 °C; 20% RH..80% RH (clean, dust-free, draft-free,

no chemicals, no dew, no condensation)

Reference Solutions - LAB_Salt (only available as Off-Site service)

Available points: 0.5% RH, 5% RH, 10% RH, 20% RH, 35% RH, 50% RH, 65% RH, 80% RH, 95%

RH at +23 °C (±3 °C)

Calibrations with salt solutions are performed in the temperature- and humidity controlled

calibration laboratory at room temperature +20 °C..+26 °C. Stable environmental conditions

are vital to achieve precise results. Calibrations with salt solutions are therefore only

offered as an Off-Site service.

Certified salt solutions are used to achieve an exact reference value. The salt solutions are

applied to a dense measuring chamber together with the probe and analysed after a

defined stabilisation period.

Environmental conditions: +20 °C..+26 °C; 20% RH..80% RH (clean, dust-free, draft-free, no chemicals, no dew, no

condensation)

In-Process Comparison - OS_InProcess

Range of use: 10% RH..90% RH at +10 °C..+40 °C

An in-process calibration is mainly used if it is technically impossible to remove the probe

for a calibration.

Therefore a one-point measurement is taken during the process (e.g. in a storage room).

The precise, traceable and calibrated reference probe is placed as close as possible to the

unit under test and the reference value is recorded over a defined period of time.

Environmental conditions test device: +10°C..+40 °C; 10% RH..90% RH (non-condensing)



3.3. Electrical Calibration

Standard calibration points and tolerances for an electrical calibration, used if customer

tolerances are not available or the customer agrees to the standard tolerances:

Data logger Calibration points Standard tolerance

ECOLOG TPx

ECOLOG-NET LP4

LIBERO Te1-P

LIBERO CE

-190 °C,

0 °C and +200 °C

± 0.5 °C (< -100 °C)

± 0.2 °C (>-100 °C)

ECOLOG TNx -0.4 °C and +73.3 °C ± 0.2 °C

ECOLOG THx

ECOLOG-NET LH2

-0.4 °C and +73.3 °C;

5.0% RH and 88.4% RH

± 0.2 °C

± 0.3% RH

ECOLOG-NET LA8 without Transmitter

ECOLOG-PRO 4MA without Transmitter

ECOLOG-NET LR8 with RA2e

4 mA and 20 mA ± 0.04 mA*

HAMSTER E -90 °C,

0 °C und +80 °C

± 0.5 °C

± 0.2 °C

ECOLOG-PRO 4PT

ECOLOG-PRO 2TH

LIBERO

No electrical calibration available

* To convert the tolerance in the given unit this formula is used: 0.04mA*Range/16mA

Example for a range of -40 °C..+60 °C or 0% RH..100% RH: 0.04mA*100/16mA = 0.25 °C or % RH

Test plugs (fixed resistance / digital value) - LAB_Electrical, OS_Electrical

Electrical references are available for all ECOLOG and ECOLOG-NET devices. The electrical

calibration is used to test the electronics of the data logger, without attached probes. The

tested/calibrated electrical reference devices transmit a value to the data logger that is

compared to the defined target value.

The electrical testing ensures that the measurement chain is tested as a whole e.g. if

exchange probes are used or as check-up before calibration.

Environmental conditions: +0 °C..+40 °C; 0% RH..90% RH (non-condensing)

4 mA..20 mA Current calibrator - LAB_Electrical, OS_Electrical

A calibrated current calibrator is used to calibrate ECOLOG-NET LA8 or ECOLOG-PRO 4MA.

The electrical calibration is used to test the electronics of the data logger, without

attached probes. The electrical reference devices transmit a value to the data logger that is

compared to the defined target value.

The electrical testing ensures that the measurement chain is tested as a whole e.g. if

exchange probes are used or as check-up before calibration.




3.4. Differential Pressure Calibration

Standard calibration points for the differential pressure calibration:


Clean room 20 Pa

0.25 in H2O

0 Pa, 40 Pa

0 in H2O, 0.5 in H2O

0 Pa, 20 Pa, 40 Pa

0 in H2O, 0.25 in H2O, 0.5 in H2O

Standard tolerances, used if customer tolerances are not available or the customer agrees to

the standard tolerances. Valid for 100 Pa Range (e.g. -20 Pa..+80 Pa or -50 Pa..+50 Pa):

Differential pressure generator - OS_dP, OS_dPSYS

Range of use: -100 Pa..+100 Pa, -0.5 in H2O..+0.5 in H2O

To calibrate differential pressure a pressure generator is used to produce a defined pressure.

The unit under test is compared to a precise, traceable and calibrated reference pressure

measuring device.

The calibration can be performed on the transmitter only (dP), or the transmitter and all the

installed pressure pipes (dPSYS).


3.5. CO2 - Calibration

Standard calibration points for the CO2-Calibration:


Incubator 5% CO2 5% CO2,

10% CO2 or 15% CO2

0% CO2 (=100% N2), 5% CO2,

10% CO2 or 15% CO2


the standard tolerances:

Reference gases - LAB_CO2, OS_CO2

Available points: 0% CO2 (=100% N2), 5% CO2 and 10% CO2 or 15% CO2

Reference gases with a certified CO2-content or pure nitrogen (as zero point) are used to

calibrate a CO2-transmitter.

The On-Site service team performs the calibration and checks the air flow of the reference

gases as well as environmental conditions in order to achieve the best possible accuracy.


As Found

± 2.0 Pa / 0.01 in H2O

deviation > 5 Pa / 0.02 in H2O

replacement

As Left

± 1.0 Pa / 0.01 in H2O

typical drift / year:

ca. 1.0 Pa or 0.01 in H2O

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As Found

± 1.5% CO2

deviation > 1.5% CO2

replacement

As Left

± 0.5% CO2


ca. 1.0% CO2

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3.6. O2 - Calibration

Standard calibration points / tolerance for the O2-Calibration:

Area of Application 2 calibration points:

Ambient 0% O2(=100% N2), 20.9% O2


the standard tolerances:

Reference gases - LAB_O2, OS_O2

Available points: 0% O2(=100% N2), 20.9% O2

Reference gases with a certified O2-content or pure nitrogen (as zero point) are used to

calibrate an O2-transmitter.

The On-Site service team performs the calibration and are to check the environmental

conditions in order to achieve the best possible accuracy.


3.7. Air Velocity

Standard calibration points and tolerances for an air velocity calibration, used if customer

tolerances are not available or the customer agrees to the standard tolerances:

Area of Application: Calibration points Standard tolerance

Air duct

Laminar flow

Clean room

1 point in-process ± 0.10 m/s (Range 0.0 m/s..1.0 m/s)

± 0.15 m/s (Range 0.0 m/s..2.0 m/s)

In-Process Comparison - OS_Flow

Range of use: 0.0 m/s..2.0 m/s

To calibrate air velocity, a one-point measurement is taken during the process (e.g. in the air

duct). The precise, traceable and calibrated reference anemometer is placed as close as

possible to the unit under test and the reference value is recorded over a defined period of

time.


3.8. Particle Counter

Test protocol:

On-site services can perform a zero filter test and take a flow measurement for particle

counters using a test protocol. The customer receives the test protocol with the results. A

calibration can be offered in cooperation with a specialised third party service provider.

As Found

± 1.5% O2

deviation > 1.5% O2

replacement

As Left

± 0.5% O2


ca. 1.0% O2

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4. Analysing Calibration Results

It is part of ELPRO's service to assess if the given measurements are accurate and fulfils the

need of the customer. Therefore the conformity is stated on the certificate. The tolerance

used is either customer tolerance or the standard tolerance stated in the chapter 3.

The conformity assessment is applied using the simple acceptance decision rule as defined in

JCGM 106:2012, 8.2. ELPRO fulfils all the requirements of chapter 8.2.4, with using a well-

characterized test method with well-known uncertainty, specified errors and limits,

environmental conditions, well-documented procedures and competency of personnel.

JCGM guidance are published jointly by all well known organizations within the metrology

and measurement business e.g. BIPM, ILAC, ISO, IEC, IUPAC, OIML and others, and therefore

deemed to be a suitable and scientific approach for all of ELPRO's customers.

The applied calibration tolerance is not to be confused with the accuracy of the device which

is stated in the datasheet of the device.

4.1. Conformity Statement

Difference of measurement <= calibration tolerance

The measuring instrument complies with the defined specifications: YES

Difference of measurement > calibration tolerance

The measuring instrument complies with the defined specifications: NO

The customer is informed if measurements outside the calibration tolerance have been

taken. The customer can decide if the device should be adjusted (not possible for all devices)

or if the device should be replaced.



4.2. Risk Assessment and Drift of Temperature Probes

The main influence in case of deviations from temperature sensors is mechanical stress,

caused by vibrations, shock, dropping e.g. on work desks or floor.

For wire-wound PT100 probes, the sensor element consists of a wire that is wound onto a

ceramic carrier. This can break due to mechanical stress and lead to deviations. In NTC

sensors, the sensor element consists of a small plate of a metal mixture, which is molded

into an epoxy resin layer. Mechanical stress can lead to cracks in the epoxy resin layer.

Temperature sensors usually have no drift / aging, since the sensor is not in direct contact

with the environment. Normally, the sensor element is encased in a metal or rubber sheath

or molded in epoxy resin. The measurement takes place only via the heat transfer to the

sensor element, since this is not directly in contact with the environment. Therefore,

chemical influences are minimized and the measurement remains stable over a long time.

Large thermal loads (extreme temperatures and temperature fluctuations) can influence the

measuring accuracy. Therefore, the sensor should only be used in the specified application

range according to the data sheet.

Water, condensation and chemical substances at the solder joints or after a mechanical

defect (see above) can increase the contact resistance and falsify the temperature

measurement. Corrosion on the connectors can also lead to falsified measured values.

All devices sent to ELPRO are checked electrically prior to calibration during a check-up,

among other tests, so that errors on the data logger are detected before the calibration. In

this case, the customer will be contacted prior to calibration to define the further procedure.

Setup of PT-100 sensor (example with wire-wound PT100 with 4-wire connection):

Setup of NTC sensor:

4.2.1. What shall be checked / prevented in daily use?

Handle the probe as carefully as possible and protect it against mechanical stress

Use only in the specified application range

Use suitable / padded transport containers and packaging

Avoid condensation, water and chemicals on the data logger, connectors and non-

watertight probes, and visually inspect in case of non-plausible values

sheath tube e.g. metal cable e.g. PFA

filling material

transition e.g. soldering

connecting wires

PT-100 sensor

connecting wires

Epoxy resin layer

sensing element

made of metal alloy



4.3. Risk Assessment and Drift of Humidity Probes

It is inevitable that the performance of all relative humidity sensors will drift over time and

due to the design and functionality. The sensor element needs to be in direct contact with

the environment to allow the air to pass through the sensor so that its humidity can be

measured. This means that the internal structure of the sensor is exposed to the air which

will inevitably be carrying some level of contaminants (for example chemicals or

condensation water). Over certain period of time these contaminants will settle on the

sensor and cause the sensor to drift. Additionally physical knocks and changing temperature

imposes stresses on the humidity sensor which is delicate in his construction. By way of

comparison, temperature sensors are not so prone to drift over time as the sensing element

is not in direct contact with the environment – normally it is encased in a metal or rubber

sheath which conducts the environment temperature and acts as a protective barrier.

Setup of a capacitive humidity sensor element:

A capacitive humidity sensor is a capacitor using a hygroscopic polymer layer as dielectric

material placed between two electrodes.

4.3.1. What shall be checked / prevented in daily use?

Ensure that the sensor is not in direct contact with cleaning agents or disinfectant

Handle the sensor carefully with no physical knocks

Prevent condensation and dust

Check packaging of the sensor during storage times:

o not be packaged in outgassing plastic materials, be very careful with bubble foils

and foam packaging

o use paper or cardboard based packaging, Metal-In antistatic shielded ESD bags

Keep stickers on the probe to a minimum

4.3.2. Procedure in case of drift

A replacement of the probe is recommended when the measurement value:

exceeds the as found calibration tolerance

of temperature probes exceeds the calibration tolerance

An adjustment of the probe is recommended, when the measurement value:

is within the as found calibration tolerance

and exceeds the calibration tolerance which would have been used for the as left

calibration

Change of

capacitance

Upper electrode made of pourus material

Hygroscopic dielectric / polymer layer

Lower electrode / conductive plate

Filter cap permeable for H2O



4.4. Defining Calibration Intervals

To define the required recalibration interval, there are two general directions:

Following a risk-based approach considering technical and process issues and evaluate

their likeliness and impact. This should be documented in a risk assessment:

o Field of application and risk of damage

o Risk for drift (ELPRO recommends to perform a drift analysis of sensors in the field of

application, additional information can be found in chapter 4.2 and 4.3)

o Environmental impact on the sensor element (see chapter 4.2 and 4.3)

o Economical risk in case of failure

Following standards or trusted guidelines of the customer’s applicable field. Examples:

o WHO guideline No. Technical 961, Annex 9, chapter 4.10.1 states that a yearly

recalibration is required unless otherwise justified.

o EU GDP 2013/C 343/01 chapter 9.2 Equipment used for temperature monitoring

during transport within vehicles and/or containers should be maintained and

calibrated at regular intervals at least once a year.

o EU GDP 2013/C 343/01 chapter 3.3 Equipment used to control or to monitor the

environment where the medicinal products are stored should be calibrated at

defined intervals based on a risk and reliability assessment.

o ICH Q7 Good Manufacturing Practice Guide for API, Chapter 5.3 Calibration Control,

weighing, measuring, monitoring and test equipment that is critical for assuring the

quality of intermediates or APIs should be calibrated according to written procedures

and an established schedule.

o ILAC “Guidelines for the determination of calibration intervals of measuring instruments” distinguishes between the initial definition of a calibration interval and the adjustment based on data collected during the life cycle (i.e. ILAC-G24:2007). For

reasons of economic efficiency (reduction of calibration costs), the test interval for

repeat tests can be dynamical chosen on basis of the results from repeat calibrations.

Corresponding methods are shown in Annex A of ISO 10012 Part 1.

o ISPE GAMP “A risk based approach to Calibration Management”. The GAMP focuses very much on the risk-based determination of intervals and offers a concrete

procedure for this. The focus here is on the influence of the measuring device on

patient safety.

o According to Swiss Accreditation Service guideline No. 740d Rev.01, page 7, a

calibration period up to 24 months is allowed for temperature measuring devices.

Finally, it is the user’s responsibility to determine the period for re-calibration in his own

responsibility with regards to his applicable standards and considering the risk of his

application. In general, ELPRO does not state the recalibration period on the certificate. In

case it is required, this must be ordered specifically.



4.5. Comparison of ISO 17025, ILAC, and International Accreditation Bodies

The international standard for calibration is ISO 17025. It covers all requirements for the

quality management system and all technical requirements to ensure competency in

calibration and testing.

ILAC is the international organization for laboratory accreditation bodies and its purpose is

to harmonize and recognize local accreditations. Therefore all signatories of the mutual

recognition agreement of ILAC are evaluated and deemed to be equal. As per 2019 there are

102 accreditation bodies as signatories of the MRA with around 80'000 accredited

laboratories. A signatories list is available on the ILAC website.

The below shown graph outlines the global approach of ILAC:

ELPRO aims for harmonized calibration for global customers; therefore the ISO 9001 quality

management system is globally certified. The next step ahead is to also globally harmonize

ISO 17025 accreditation. Therefore the logos might not be the well known one in your

country. However the same standard ISO 17025 is used by all the ILAC signatories (e.g.

UKAS, DAkkS, ANAB, SINGLAS, etc.) and ELPRO ensures high quality calibrations for all its ISO

17025 calibrations.

Which requirements are covered by ISO 17025?

One part of ISO 17025 is the management system requirements, which are equivalent to ISO

9001. The main technical topics covered by ISO 17025 to ensure technical competency are:

Personnel and training

Environmental conditions during calibration

Suitable equipment (e.g. reference equipment) and its periodic calibration and testing

Metrological traceability -> which is the traceability to the national standards defined in

ISO/IEC Guide 99 as a documented unbroken chain of calibrations, each contributing to

the measurement uncertainty, linking them to an appropriate reference.

Verification and validation of methods for calibration and testing, to ensure the chosen

methods are suitable for the intended use

Handling of customer items

Suitable technical records to document the calibration, ensuring reproducibility

Evaluation of the measurement uncertainty

Logos

Accreditation Bodies

Global Harmonisation

(mutual recognition agreement)

International Standard ISO 17025

ILAC Signatories

Switzerland SAS/SCS

United Kingdom

UKAS

United States of America

ANAB

Germany DAkkS

...

http://ilac.org/signatory-search/



Ensuring long-term validity of the results (e.g. through proficiency testing)

Reporting of the results in calibration certificates, including requirements for conformity

statements

What does the ELPRO certificate look like?

The content of calibration certificates according to ISO 17025 are defined in the standard.

Therefore all information the customer gets from different accredited calibration certificates

are the same. No matter if there is a UKAS logo, an ANAB logo, an SCS logo or a DAkkS logo

on it. Each accreditation body has a defined template which is used by the laboratory.



4.6. Measurement Uncertainty

Each measurement is associated with a measurement uncertainty (U95 resp. k=2) which

quantifies the range within the true value is expected to be.

At ELPRO, all factors (e.g. homogeneity and stability of the calibration medium, stability of

the measurement, imported measurement uncertainty of the reference, aging of the

reference, effect of environmental conditions a.m.) affecting measurement uncertainty are

taken into account. ELPRO therefore complies with the ISO 17025 and GUM requirements.

The lowest possible uncertainties are available in the Scope of the laboratory, which is

available on the ELPRO website.

Calibration Method Target Value U95 ISO 17025 U95 Factory

Ice-Water 0 °C 0.11 °C 0.13 °C

Dry Ice / Alcohol -78 °C 0.27 °C2 0.27 °C2

Liquid Nitrogen (LN2) -196 °C 0.21 °C 0.26 °C

Dry Block Calibrator -90 °C..+150 °C 0.21 °C 0.27 °C

Liquid Bath -80 °C..+90 °C 0.17 °C 0.21 °C

In-Process Temperature -196 °C..+150 °C - 0.81 °C1/2

Humidity Calibration with

Saline Solution

at +23 °C ± 3 °C

0.5% RH, 5% RH, 10% RH 0.4% RH1 0.5% RH1

20% RH 0.5% RH1 0.6% RH1

35% RH 0.7% RH1 0.9% RH1

50% RH, 65% RH 1.0% RH1 1.3% RH1

80% RH, 95% RH 1.3% RH1 1.6% RH1

Humidity Generator

10.0% RH..50.0% RH

Temperature +20.0 °C..+26.0°C

Environment +20.0 °C..+26.0°C

1.1% RH

0.36 °C

1.3% RH

0.45 °C

50.1% RH..90.0% RH

Temperature +20.0 °C..+26.0°C

Environment +20.0 °C..+26.0°C

1.33% RH

0.36 °C

1.66% RH

0.45 °C

10.0% RH..50.0% RH

Remaining Measuring Range

1.4% RH

0.46 °C

1.75% RH

0.57 °C

50.1% RH..90.0% RH

Remaining Measuring Range

2.12% RH

0.46 °C

2.64% RH

0.57 °C

In-Process Temp. / Humidity 10% RH..90% RH @ +10 °C..+40 °C - 2.62% RH

0.66 °C

Electrical Calibration

NTC 0.10 °C

PT100 0.12 °C / US Scope: 0.14 °C2

Humidity 0.10% RH

4 mA..20 mA (Depending on Units & specified

range) 0.011 mA (MU=0.011mA*Range/16mA)3

Differential Pressure -100 Pa..+100 Pa / -0.5 in H2O..+0.5 in H2O

(without pressure pipes)

0.99 Pa

3.82x10-3 in H2O 2

1.23 Pa

3.82x10-3 in H2O 2

CO2 0% CO2, 5% CO2 0.22% CO2

1

10% CO2, 15% CO2 0.42% CO21

O2 0% O2, 20.9% O2

In-Process Air Velocity 0.00 m/s..0.99 m/s - 0.08 m/s1

1.00 m/s..2.00 m/s - 0.13 m/s1

In-Process Volume Flow

Rectangular Channel (HQM-100) - calculated, around

300 m3/h1

Round Channel (HQM-FC) - calculated, around

400 m3/h1 1 Based on SD_CH_V7E 2 based on SD_US_V8E 3 Example for a range of -40 °C..+60 °C or 0% RH..100% RH: 0.011mA*100/16mA = 0.07 °C or % RH



5. Example ISO 17025 Calibration Certificate (SCS 0122)



6. Example ISO 17025 Calibration Certificate (ANAB L2357)



7. Example Factory Calibration Certificate

elpro on-and off-site-service beschreibung · 2019. 7. 5. · warehouses, from risk analysis ......

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