Quality in

Sterilization

M E D I C A L P A C K A G I N G

TM

MEDICAL PACKAGING

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SPSmedicalSterilization Monitoring • Packaging • Testing Services

We are one of the leading importers and

distributors of sterility & infection control range of products.

Meeting regulatory medical standards, these are procured from

reputed and well established manufacturers based around the

world. Presently, we are associated with companies like VP

Stericlin, Surgeine Health Care India (Pvt.) Ltd., Microgen, SPS

Medical & Shanghai Jianzhong Medical Packaging Co. Ltd.

The range we deal in include flat Sterilization reels, wrapping paper,

indicator tapes, chemical integrator, absorbent tray liner, bowie &

dick test pack, gusseted reel, surgical gowns & drapes and

Disinfectants.

Established in the year 1994, at New Delhi, More than a decade of

industry experience and keen interest in the upcoming products in

the medical industry assists our procurement team to source the

right range of products as specific demands of medical fraternity

based in India. Further the penetration of our marketing and sales

arm allow better product visibility to manufacturers of sterility,

infection & anesthesia range of products in the domestic markets.

Today, our consistent efforts towards successfully meeting the

needs of demand and supply has helped us to achieve revenue of

approximately USD 1.3 million/annum. Further our direct

distributorship status with manufacturers also assure our domestic

clients of sourcing genuine range of medical products at competitive

prices.

“Manocha Surgicals,”

PACKAGING - A Life or Death Matter

From a very early age, we are all taught a healthy respect

for bacteria! We know how sturdy, tough and resilient

bacteria are: we also know that the only sure way to

counteract them is by "STERILISATION".

A fairly simple concept in principle, but the secret of

effective sterilisation is to ensure that a medical device

once sterilized maintains that sterility up to the point of

use. In the context of healthcare procedures, effective

sterilisation requires a packaging material.

If sterility is to be maintained, the packaging material used

needs to be a proven bacterial barrier. Instruments,

devices, dressings, etc. all need to be sterile at the point

of use. To achieve this in today's healthcare environment

requires effective packaging.

Very few of us give much thought to the packaging of an

operating procedure pack or a singleuse syringe. We

generally take it for granted that whatever is removed

from a pack which has been subjected to a sterilisation

cycle is actually sterile when used. What is it that gives us

this level of confidence? In short - it can only be the

packaging and its integrity!

Without the development of medical packaging

materials, the range of devices, packs and kits which

accompany the development of increasingly

specialised operating techniques would not be

possible. It is a point of debate as to whether or not

current standards of healthcare practice would be

feasible without the availability of a sophisticated range

of specially developed packaging materials. Continuing

technical development of packaging materials will lead

to further improvements within the medical device

industry and the hospital.

Inadequate packaging will lead to a loss of product

sterility which in turn can have a devastating effect on

the rate of hospital post-operative infection.

Having established the fact that packaging performs

the essential function of protection, we need to

consider the long-held view that the level of

protection is considerably enhanced by using a

minimum of two layers - in other words by double

packaging/wrapping.

Sterilization Reels

The Usage

The sterilization reels offered by us are constructed from

medical sterilization paper and multilayer barrier films. These

also come printed with double sterilization indicators for

providing information on ethylene oxide & steam vapor

processes.

1. Choose the proper size pouches as per the size of the

equipment's to be sterilized. And then put the clean &

dry equipment into the pouches. While packing the

equipment, please note; leave 3-4 cm of space more

than the equipment's height, to ensure the seal

successfully and avoid the bursting of the pouches.

2. Put the film side of the pouches against the heat bar of

the heat seal machine.

Sterilization ReelsSTEAM, EO

3. Put the closed pouches into the steam clave or ETO sterilizer according to the rule to let the pouches paper side

against paper side and than do the sterilization as per the normal methods.

4 To identify the situation of indicators colour change : sterilization proceeded, it will turn black from initial blue

based on steam sterilization method and will turn brown from initial pink based on the ETO sterilization method.

5. The valid period will be six months on the steam sterilization method basis and will be 24 month on the ETO

sterilization method.

6. Do not use if the pack is damaged.

Code no. Size (in inches) Size (in cm) Shipping Unit

41055 2 1/6 55 x 200 m 8 rolls/Ctn

41075 3 75 x 200 m 7 rolls/Ctn

41100 4 100 x 200 m 4 rolls/Ctn

41150 6 150 x 200 m 3 rolls/Ctn

41200 7 4/5 200 x 200 m 2 rolls/Ctn

41250 9 4/5 250 x 200 m 2 rolls/Ctn

41300 11 4/5 300 x 200 m 1 rolls/Ctn

41350 13 4/5 350 x 200 m 1 rolls/Ctn

41400 15 3/4 400 x 200 m 1 rolls/Ctn

Heat-Sealing Flat Reel

TM

MEDICAL PACKAGING

Code no. Size (in inches) Size (in cm) Shipping Unit

42100 4 (100 +50) x 100 m 8 rolls/Ctn

42150 6 (150 +50) x 100 m 7 rolls/Ctn

42200 7 4/5 (200 +55) x 100 m 4 rolls/Ctn

42250 9 4/5 (250 +60) x 100 m 3 rolls/Ctn

42300 11 4/5 (300 +65) x 100 m 2 rolls/Ctn

42350 13 4/5 (350 +70) x 100 m 1 rolls/Ctn

42400 15 3/4 (400 +75) x 100 m 1 rolls/Ctn

Heat-Sealing Gusseted Reel

Summary of important rules

Sterilisation methods and appropriate packing

• Use/sterilise sterilsation packaging only once.

• Re-pack after interrupted sterilisation process or after expiry (DIN 58953, clause 7.9)

• Packages that are still moist 30 minutes after sterilsation have to be regarded as not sterile and

therefore must be separated and re-packed!! (DIN 58953, clause 7.7)

• Packages containing residual moisture should never be touched, or only with disinfected hands.

• Humidity and water drops must be avoided during storage.

• Storage conditions : ordinary room climate with 15-25°C, 40-60°C RH, short time and non

condensing max. 70% RH.

• Avoid : contact with disinfectants. Take care when disinfecting sterile storerooms and cupboards.

Sterilisation Steam Formaldehyde E.T.O - gas H O - plasma hot air2 2

packaging

see-through1) 2)EN 868 - 5 yes yes yes no no

1) 2)Wrapping paper yes only partly yes no no

3)EN 868 - 2 recommended PaperbagEN 868-4

®TYVED +

4) 5) 5) 2)PETP /PE no very good very good yes no

PA- film no no no no yes

PETP/PE : polyster / polyethylene

® .TYVEK : spun bonded polyethylene fibres, high resistance to tearing, excellent barrier quality, lowest absorption of sterilsation gases

PA: polyamide (nylon), air impervious, only for dry heat.

1) The H O - low temperature plasma sterilsation method is incompatible with the cellulose of the paper, therefore no paper, 2 2

based packaging.

2) All paper packages are not sufficently heat resistant and therefore inflammable.

3) Paper-Film-Pouches maintain lower residual Formaldehyde that pure paper packages.

4) TYVEK° as well as PE-films are not resistant to the temperatures during steam sterilsation!

5) TYVEK° absorbs in comparison to paper 100 times less formaldehyde or E.T.O - gas = lower residues, shorter degassing times.

Packs according to EN 868 & DIN 58953 are suitable for the common methods of sterilsation in hospitals :

Steam, EO-gas and Formaldehyde. Due to the characteristics of the materials used the packages differ in their

suitability for the different sterilisation methods. The recently introduced low temperature plasma sterilisation

requires totally different packaging due to its effect on organic materials. The following schedule shows clearly

the suitability of the sterilisation packaging for different sterilisation methods.

See-through-pouches®

and see-through-reels flat Tyvek

with PLASMA - and EO-Indicator - ISO 11607, CE

M E D I C A L P A C K A G I N G

Article No. Size in cm Pack (pcs.)

3FKFB250105 7.5 X 20 1000

3FKFB250110 10 X 27 500

3FKFB250115 15 X 30 500

3FKFB250120 20 X 40 500

3FKFB250125 25 X 48 500

®See-through-pouches - Tyvek

The material strength is the most important thing when it comes

to the use of medical packaging: The stronger or thicker the

material the stronger the resistance is and as a result the ®

application safety - for yourself and your patients. Stericlin uses

solely the strongest medical quality 1073 B with special water 2resistant coating and a strength of 75 g/m . The result speaks for

itself: effective barrier quality and a extremly high puncture and

tear resistance.®

Tyvek is suitable for the H O -plasma-low-temperature 2 2

sterilization, ETO-gas, Formaldehyde and ?-ray-sterilization. ®

Tyvek is not suitable for steam-sterilization!

Pouches and reels are printed with indicators for plasma and EO.

The indicators do not change their colours after the process

under normal conditions. Another characteristic feature: the film peels easy and clean without linting.

For see-through pouches commonly available continuous sealing devices are most suitable. Small tolerances in

temperature for each sealing device have to be fixed before use from case to case. The sealing temperature should

be in the range of 120° - 130°C.

Attention: higher temperatures could damage your sealing machine!®Tyvek is a registered trademark of DuPont.

Article No. Size in cm Pack (reels)

3FKFS250204 7.5 2

3FKFS250206 10 2

3FKFS250210 15 1

3FKFS250212 20 1

3FKFS250214 25 1

3FKFS250216 30 1

3FKFS250218 38 1

®See-through-reels - Tyvek - length : 100m

Indicator Tapes

Features:

Indicator and fixing indicator tapes offered by us can be used in

a variety of ways by cssd´s. Coming with indicator-ink that

shows by changing color if the sterile good has undergone

sterilization process, these indicator tapes can be used with

packaging systems like crepe wrapping paper as well as with

non-woven materials.

• Approximately 5 cm long pieces of tape are enough for

fixing packaging around sterile good

• Blue colored strong adhesive tape provides high tack, and is

especially suitable for non- wovens

• Beige-colored tape is for crepe wrapping paper

Indicator - and Fixing Tapes

For STEAM, EO and Dry-Heat Sterilisation

M E D I C A L P A C K A G I N G

Note:

• Storage instructions are printed on the cardboard box.

• Tapes with & without indicator have shelf life of 2 year after date of manufacturing

• Tapes designed for single use only

• Use only non-toxic and sterilization-proofed pencils for writing on tapes

• Do not stick pieces of tape to metal surfaces e.g. sterilization containers (residues of the adhesive could be left).

These contaminations are not easy to remove.

Order No. Article No. Description Pack (reels)

1084 4FZBH421001 STEAM 48

1083 4FZBH421003 STEAM, strong adhesive, blue for non-woven 48

1086 4FZBH421002 EO 48

890102 4FZBH421005 Dry heat 48

Indicator tapes 19 mm X 50 m

Order No. Article No. Description Pack (reels)

1093 4FZBH421004 STEAM 36

Indicator tapes 25 mm X 50 m

Order No. Article No. Description Pack (reels)

1096 4FZBH422001 19 mm X 50 m 48

1096-03 4FZBH422004 19 mm X 50 m, strong adhesive, blue for non-woven 48

1097 4FZBH422002 25 mm X 50 m 36

890311 4FZBH422005 50 mm X 50 m 20

Fixing tapes without indicator 19 mm X 50 m

Bowie and dick test pack offered by us are single use test packs that

allow users to successfully perform daily Bowie & Dick test in an

effective & simple way. The advantages of single use test pack is that

it is absolute safe in handling & reproducible in results.

• Single test pack complies to requirements of ISO 11140-4

• Independently tested & certified by third party

• Inserted test sheet change color from blue to pink during

proper sterilization

• Color change is not reversible, which ensure that

documentation done is absolutely safe

• Indicator is free of heavy metals

• Place the test pack in sterilizer

• Run Bowie & Dick test program of sterilizer

• Replace the test pack

• Check the result

Features:

Usage:

Bowie & Dick Single use Test Pack -certified to ISO 11140-4

Note:

• Instructions for use are printed onto the test pack both in

English & German language

• Space for fill in sterilizer no. & name that allow traceability of

the test pack

• Information concerning date of production, shelf life, lot no. &

recommended storage conditions given on back side of each

single test pack®• SteriCLIN single test pack’s shelf live is 4 years from time point

of production

Easy handling - reliable - free of Heavy Metals

The Bowie & Dick-test sheet

Unprocessed Processed (Pass)

M E D I C A L P A C K A G I N G

Sterilization wraps are tear proof and resistant non-woven material made of polypropylene which is suitable for heavy duty applications. Four layer material is made of two layers of spunbond which ensure extraordinary flexibility and drapeability and two meltblown layers form an efficient barrier against bacteria. Two sides with different tones enables to easily identify tears/damage to sterilized packs.

Surface : Smooth surface pattern allows adhesive tape to stick better, providing a strong seal.

Strength : Stronger material provides more resistance to punctures and tears, keeping packaged contents sterile.

Anti-Static : Coating prevents workers from repeated static "shocks" while wrapping. This is also a safety precaution against oxygen-rich OR environments.

Drapeability : Allows for wrapped items to be tightly packed, reducing the chance or external contaminants to penetrate through gaps.

Permeability : Allows steam, ethylene oxide and plasma sterilization compatible.

Low Linting : To reduce the risk of operating theatre contamination.

Packing : Packed in international standard cartons and labelled with all information regarding colour, size & type. To prevent from dust particulate and for easy identifications.

Sterilization wraps conforms to ISO 11607:2006 (Packaging for terminally sterilized medical devices) and provide CE mark product for quality assurance.

Features :

Note :

SURGEINE®

Sterilization Wraps

Regular Wraps

Sizes (In cm) Pcs./Box

45 x 45 1000

50 x 50 1000

60 x 60 1000

75 X 75 250

90 x 90 250

100 x 100 250

120 x 120 250

135 x 135 150

The STEAMPlus Sterilization Integrator is an "advanced

technology" medical device that provides a simple, accurate

method of assuring that proper conditions for sterilization

have been met during a sterilizer cycle. Certified for use

with all Steam processes (gravity, dynamic air removal

and flash), the STEAMPlus Class 5 Integrator has

documented performance equivalent to a biological

indicator.

The STEAMPlus Sterilization Integrator is engineered to

integrate the three (3) critical variables of sterilization: time,

temperature, and saturated steam. This information is

displayed in a precise, easy-to-read format. When the dark

bar enters the blue SAFE area, sterilization criteria has been

met. If the dark bar does not rcach the blue SAFE area,

proper conditions for sterilization havc not been achieved

and the processed items should not be released.

Some common causes of sterilization failure are:

• overloading the chamber

• air pockets within the sterilizer

• packs wrapped too tightly

• malfunction of the timing mechanism - error in the temperature setting

• load configuration

• poor steam quality

The base of the STEAMPlus Integrator is made of aluminum

foil, 3 mils in thickness. A cavity embossed in the foil holds

the temperature and steam-sensitive chemical which is

designed to melt when subjected to a steam environment.

The foil also acts as a moisture barrier against steam during

the sterilization cycle.

As moisture penetrates the polymeric cover film, it lowers

the melting point of the chemical. When melting occurs, the

liquid chemical is soaked up by the paper wick and, as time

elapses, moves along the scale. The rate of melt produced

is a function of both the moisture-vapor transmission rate of

Description

Technical Design

the cover film and the melting point depression of the

chemical. The combination of these two factors provides

a rate of melt at various temperatures which parallels the

thermal death time of Geobacillus stearothermophilus

spores.

How to Use the STEAMPluS™ Steam

Sterilization Integrator

Special Note:

I. Place a STEAM Plus Integrator within every package,

tray or rigid container system to be sterilized.

2. Process the load according to the sterilizer

manufacturer's instructions.

3. Retrieve the STEAMPlus Integrator at time of use,

observe the STEAM Plus Integrator for proper

movement into the blue SAFE area.

If the dark bar has not entered into the blue SAFE area,

DO NOT release the package. Proper sterilization has

NOT been achieved and the items in the package should

be reprocessed. Prior to reprocessing, be sure to check

the sterilizer for proper use and function.

SPSmedicalSterilization Monitoring • Packaging • Testing Services

STEAM Plus™ Class 5Steam Sterilization Integrator

UNPROCESSED

PASS

FAIL

www.vp-group.de

The reprocessing of modern hollow instruments needs reliability of

the highest level for all reprocessing steps. The monitoring of steam

sterilisation should combine parametric control and the use of a

specific process challenge device (PCD) with a chemical indicator. It

monitors air removal and steam penetration within critical

instruments. The BMS signals that sterilisation parameters have

been met through the simulation of the critical sterile goods.

Stericlin’s BMS simulates modern hollow instruments perfectly in

terms of material and mass. The long and narrow channel of the

PCD makes high demands on air removal and complete steam

penetration. The BMS is designed to monitor steam sterilisation

processes with a fractionated vacuum.

If the colour change of the chemical indicator is uniform, and if the

measured parameters are within tolerances, the batch may be

released - with the knowledge that the hightest process safety has

been achieved. The stericlin® BMS fulfils the requirements of the

performance testing according to EN 867-5 5.3 - 5.3.3.2.

BMS Batch Monitoring System

Article-No. Description Pack (pcs.)

3FSKS630104 Starter Kit (1 PCD, 2 capsules, 250 indicatorstrips)

1

3FSKS630102 Indicatorstrip

(incl. 1 capsule) Size: 76,5 x 5,5 mm

250

BMS Batch Monitoring System

From safety experts for safety experts

6-30 E

11/2009

Rev. 0

Manocha Surgicals

21, Central Market, Shop No. 6,

(Lower Ground) Ashok Vihar,

Phase - 1, New Delhi - 110 052. INDIA

Phone : +91-11-27134154

Fax : +91-11-27130274

Mob.: +91-9811363905

Email : manochasurgicals@yahoo.co.in

Web : www.manochasurgicals.com

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