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Jasdeep SinghHead of PMURoyal London Hospitaljasdeep.singh@bartshealth.nhs.uk

Can we start validating the Baxa EM2400?

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Overview

• Introduction

• Barriers

• Process Development

• IQ

• OQ

• PQ

• Implementation

• EM2400 User Group

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Introduction• PN compounding highly complex

1. Multiple ingredients

2. Relatively large volume transfers

3. Compatibility issues

4. Microbiological contamination risk

• Vacuumat

• Baxter Automix

• MM Series of Compounders

• Superceded by EM series of compounders

1. EM2400

2. EM1200

• Semiautomated, computer controlled PN compounding machines

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Automated compounder with Baxa Coumpounders

• First machine MM Series

1. Direct fill using peristaltic pump

2. No data re-input information transfer by ascii file for

– Via software interface

3. 13 or 23 inlets

• 2nd Generation EM2400

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2nd Generation of Baxa compounders

• ExactaMix (EM) 2400

• Integrated computer module

• Integrated balance

• Improved speed

• Software development running the compounder

with more safety features

A great deal more complexity with the improved

usability and a great deal of unknowns!!

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Process of PN supply

• Development of the whole process of PN

manufacture where by the compounder plays a

key but not sole role.

• Prescription input system

• Assembly and compounding of PN

• Release process

• Packing and Dispatch

Risk Assessment is key to the final process design

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Ishikawa cause-effect diagram for the process of producing paediatric parenteral nutrition formulations.

Bonnabry P et al. Qual Saf Health Care 2005;14:93-98

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PN Manufacture Process Map

Receive

Prescription

Input Formula into W/S

labelling software

Check

formula

Assemble

bulk

materials

Transfer

electronic

file

Assemble

empty bag

with w/s

Release Bag

Compound

PN Mix check

report printed

Pass out bag and materials

Set up

compounder

Sanitise into B areas

Confirmation of QC checks

Samples to QC

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Set up of the Formulation and Compounder Interface

Server

LPHRM1

Workstation

WS8713

Ascribe v 8.6 Creates

Pat Data File as ascribe

file

Workstation

WS8717

Ascribe v 8.6

Creates Pat Data File as

ascribe file

Workstation

WS6318

Ascribe v 8.6 Creates

Pat Data File as ascribe

file

EM2400 Compounder 1

Compounder accesses the relevant

folder for the Pat data

EM2400 Compounder 2

Compounder accesses the relevant

folder for the Pat data

ASCII Pat Data File Folder for

Compounder 1

ASCII Pat Data File Folder for

Compounder 2

Ascribe Interface module converts Ascribe

Pat Data file into a ASCII format Pat data file

and places onto appropriate folders on the

server

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Process Development

• Rationalisation of ingredients and strengths

• General Set up and draw up of syringes

Identifying Mistakes

• Data transfer (manual or electronic)

• Flush volumes

• Minimum pump volumes

• Methods of testing (for validation and routine)

• SOP’s & Logs

• Training Modules

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What are you trying to validate

• The EM2400

• The formulation system software interface

• The network

• Operators

• Ingredients

Flow Factors

• What bags are you making All in one / aqueous bags or

only bulks

• Make assumptions for worst case scenarios but this an improvement on the manual process

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Installation Qualification (IQ)

• Do all the separate components fit

• Power up and boot up

• Communications with network

• Software versions/ drivers (touchscreen & printers)

• Antivirus software and updates

• Print to printer(s)

• Barcoding

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IQ

• Version of operating system and updates

• Record serial numbers of each component

• CE markings

• PAT (Portable appliance testing)

• Size of hard drive and memory occupied

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Operational Qualification (OQ)

• Security

• Generate and Delete Data to databases

• Pump a Formula

• Balance check

• Report Generation

• Interruptions in power and data supply

• Verification of databases of W/S labelling

system and Exactamix program

• Concurrent running of multiple compounders

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OQ Testing overall tests

• Alarm testing

1. Occlusion

2. Bubble

3. Unsteady pan

balance

4. Tube set expiry

5. Too little UI

6. Manual addition

7. Incompatible ingredients

• Weighing the bags

• USB entry

• Direct Entry

• Pump head not

alligned

• Pumping out of

range

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Performance Qualifcation(PQ)

• Minimum Flush Volume

1. Dependant on ingredients

2. Varies between compounders

3. Used a spiked ingredient with a nominal volume of

20ml

4. Acceptance 0.5% of original concentration but

achieving in the range of 1 tenth of that.

5. In practise added a further 5ml to ensure flush with

any other variations

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PQ

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PQ Minimum Volume

• Minimum volume

1. Technical Manual states can pump 0.2ml to the

nearest 0.02ml

2. This is dependent on the particular ingredient and

what it is being flushed with

3. We got values of 0.5ml

4. In practise we use a minimum volume of 0.6ml

– 95% of bags made without manual additions by adjusting overage

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PQ Broth validation

• Looked at pumping smaller volume bags with

small reservoir containers for maximum number

of changes/ manipulations

• Ran over an extended day by 3 hours

• Left lines static for long periods of time and

pumped a total of 60 bags

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Development of analytical methods

• Issues to consider

1. Flush volume in relation to various ingredients problems with fat and 70% glucose

2. Minimum volume with dilution using flush volume sensitivity problems

3. Setting appropriate limits to ensure minimal manual

additions

• Routine testing what and how

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Revalidation

• During use have had to replace key

components and have to reproduce modular

validations to assess the impact of that

replacement

• Ongoing Broth every 6 months but done at the

end of a working day with less broth bags

Problems of removing fat from inlet lines

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Costs

• Difficult to approximate as a lot of time spent

with development

• With staffing, equipment and materials could be

in the region of £100K!!!!

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NHS EM2400 User Group

• Facilitate rapid implementation of the

compounder into units

• Support validation

• Support wider initiatives of sourcing bulk

ingredients

• Develop standards

• Sharing experience

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Acknowledgements

• Ron Lythgo (QC lab manager)

• Jeremy Egerton (Graduate Technician)

• Chris Jeffrey (Senior Technician)

• Jakin Patel (Graduate Technicican)

• All the staff in PN at PMU

• Seb Hodgkin (Head of Quality)