Product catalog CLEANROOMS ASEPTIC PROCESSING CONTROLLED ENVIRONMENTS

Transcription

1 Product catalog CLEANROOMS ASEPTIC PROCESSING CONTROLLED ENVIRONMENTS 1

2 At Berkshire we have developed an outstanding reputation for our products, innovation and added value. While these are vital components of our ongoing success and growth, our first priority is to meet our customers needs, and even exceed their expectations. We pride ourselves on flexibility, responsiveness and personal contact at the most local level. With facilities throughout Europe, America and Asia we bring together a vast range of skills, experience and expertise yet still have the ability to focus our delivery on each individual client. 2

3 Introduction Global service and support With facilities through Europe, America an Asia, Berkshire is a global leader in developing and manufacturing products for critical and controlled environments. From its origins in the USA in 1967, Berkshire developed a global presence in the 1980 s, with the creation of European and Asian operations. These operations grew to provide manufacturing, logistics and product development alongside excellent customer service and support. Our highly qualified people will offer you unparalleled service and value. Our products deliver superior performance, quality, enhanced productivity, and the lowest total cost in use. Quality Our focus on making the best contamination control disposables in the world is fundamental. Berkshire ensures the delivery of high-quality products through constant improvement in process control. CORRECTIVE & PREVENTIVE ACTION (CAPA) SYSTEM Berkshire is committed to the constant adherence to and improvement of the following methods and principles of process control: Vertical Integration of the Raw Material Supply with Berkshire Processes Dedicated Processing Equipment Process Management Plans Raw Material Specifications Supplier Testing Coupled with Incoming Inspection Change Control Management Change Validation Closed-Loop Corrective Action in Excursion Management PROCESS CAPABILITY This measure is used to objectively quantify the degree to which a process is or is not meeting its requirements. Process capability measurements and analysis with goals of Cpk>1.33 (Six Sigma) for all critical parameters. PROCESS FMEA The result of the process is the generation of action plans to prevent, detect or reduce the impact of potential modes of failure. Berkshire ensures delivery of the highest quality and most consistent products through constant focus on and improvement of Process FMEA in design and manufacturing. STATISTICAL PROCESS CONTROL (SPC) Using statistical techniques, we monitor the quality of our processes and products to ensure the delivery of the highest quality and most consistent products possible. Please visit our website at to learn more about our technology and process control For a consultation or finding your local representative, please contact us on: Tel : +44 (0) Fax: +44 (0) enquiries@berkshire.uk.com 3

4 Table of contents Introduction 3 Table of contents 4 Quick overview wipers 5 1 Wipers Sterile Wipers 7 Sterile Dry Wipers 8 Sterile Pre-Wetted Wipers Dry Wipers 10 Knitted Polyester - Sealed Edges 10 Knitted Polyester - Knife-Cut 14 Knitted Polyester - Unlaundered 15 Knitted Polyester - Laundered Open-Cell Polyurethane Foam 15 Microfiber 16 Non-Woven & Woven Pre-Wetted Wipers 20 Critical Process 21 Controlled Process 22 2 Mops & Accessories 23 Flat Mop Wipers 23 Flat Mop Heads 24 Folding Flat Mop Covers 25 Folding Flat Mop System 26 3 Isolator Cleaning Tool 26 4 Face Masks 27 5 Glove Liners 29 6 Documentation Systems 30 Cleanroom Paper Notebooks 7 Swabs Sterilisation Validation Process 36 4

5 Quick overview wipers Quick Overview of Sterile Dry Wipers STERILE DRY WIPERS MATERIAL RECOMMENDED CLASS EDGE APPLICATION Gamma Wipe SuperSorb Knitted Polyester ISO Class 3-5 Sealed Edge Critical Gamma Wipe 300 Knitted Polyester ISO Class 3-5 Sealed Edge Critical Gamma Wipe 120 Knitted Polyester ISO Class 4-5 Knife-Cut Critical Gamma Wipe 67 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Quick Overview of Sterile Pre-Wetted Wipers STERILE PRE-WETTED WIPERS MATERIAL RECOMMENDED CLASS EDGE APPLICATION Sterile Satpax HA Knitted Polyester ISO Class 3-5 Sealed Edge Critical Sterile Satpax 1200 Knitted Polyester ISO Class 4-5 Knife-Cut Critical Sterile Satpax 1000 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Sterile Satpax 670 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Quick Overview of Pre-Wetted Wipers PRE-WETTED WIPERS MATERIAL RECOMMENDED CLASS EDGE APPLICATION Satpax 3000 Knitted Polyester ISO Class 3-5 Sealed Edge Critical Satpax HA-R Knitted Polyester ISO Class 3-5 Sealed Edge Critical Satpax 120-R Knitted Polyester ISO Class 4-5 Knife-Cut Critical Satpax 1000 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Quick Overview of Dry Wipers Satpax 1000 Canister Nonwoven Polyester/Cellulose ISO Class 5-8 Pre-perforated Controlled Satpax 670 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Satpax 550 Polypropylene ISO Class 5-8 Knife-Cut Controlled 5

6 Quick overview wipers Quick Overview of Dry Wipers KNITTED WIPERS MATERIAL RECOMMENDED CLASS EDGE APPLICATION MicroSeal SuperSorb Knitted Polyester ISO Class 3-5 Sealed Edge Critical Ultra-Seal 3000 Knitted Polyester ISO Class 3-5 Sealed Edge Critical MicroSeal 3000 Knitted Polyester ISO Class 3-5 Sealed Edge Critical Choice SuperSorb Knitted Polyester ISO Class 3-5 Sealed Edge Critical MicroSeal 1200 Knitted Polyester ISO Class 3-5 Sealed Edge Critical CapSure -VP Knitted Polyester ISO Class 3-5 Sealed Edge Critical MicroSeal -VP Knitted Polyester ISO Class 3-5 Sealed Edge Critical ValuSeal-HA Knitted Polyester ISO Class 3-5 Sealed Edge Critical ValuSeal -LP Knitted Polyester ISO Class 3-5 Sealed Edge Critical ValuSeal 1500 Knitted Polyester ISO Class 3-5 Laser-Cut Critical ValuSeal IonX Knitted Polyester ISO Class 3-5 Laser-Cut Critical Super Polx SWSE Knitted Polyester ISO Class 3-5 Sealed Edge Critical Super Polx LWSE Knitted Polyester ISO Class 3-5 Sealed Edge Critical Super Polx 1200 Knitted Polyester ISO Class 4-5 Knife-Cut Critical Super Polx 1200A Knitted Polyester ISO Class 4-5 Knife-Cut Critical Super Polx SW Knitted Polyester ISO Class 4-5 Knife-Cut Critical Polx 1200 Knitted Polyester ISO Class 5-8 Knife-Cut Controlled POLYURETHANE FOAM MATERIAL RECOMMENDED CLASS EDGE APPLICATION PureSorb Foam Wiper Polyurethane Foam, Open-Cell ISO Class 3-5 Laser-Cut Critical MICROFIBER WIPERS MATERIAL RECOMMENDED CLASS EDGE APPLICATION MicroPolx 2750 Polyester/Nylon Microdenier ISO Class 4-5 Sealed Edge Critical MicroPolx 4000 HP Polyester/Nylon Microdenier ISO Class 4-5 Sealed Edge Critical NON-WOVEN WIPERS MATERIAL RECOMMENDED CLASS EDGE APPLICATION BlueSorb 750 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Durx 770 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Durx 670 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Durx 670-Roll Nonwoven Polyester/Cellulose ISO Class 5-8 Pre-perforated Controlled Exsorbx 400 Nonwoven Polyester ISO Class 5-8 Knife-Cut Controlled Pro-Wipe 750 Polypropylene/Cellulose ISO Class 5-8 Knife-Cut Controlled Pro-Wipe 880 Polypropylene ISO Class 5-8 Knife-Cut Controlled ValuClean Plus Polyester/Rayon ISO Class 5-8 Knife-Cut Controlled Lensx 90 Rayon/Hemp Blend ISO Class 6-8 Knife-Cut Controlled WOVEN WIPER MATERIAL RECOMMENDED CLASS EDGE APPLICATION Twillx 1622 Woven Cotton ISO Class 6-8 Knife-Cut Controlled 6

7 1 Wipers 1.1 Sterile Wipers STERILE WIPERS Berkshire s Gamma Wipers are designed for aseptic applications. Validated sterile, with full lot tracking and certificates of sterility available online, these wipers are manufactured to the highest standards and in accordance with our ISO 9001 certified system. They are very low in particles and fibers and provide high levels of absorbency. KEY BENEFITS Validated sterile according to ANSI/AAMI/ISO procedures Gamma irradiated to a 10-6 Sterility Assurance Level Certificate of Sterility available online, by lot number at * Details: Expiration Date, Radiation Dosage, Lot Information, Meets cgmp requirements for traceability Quick Overview of Sterile Dry Wipers WIPER MATERIAL RECOMMENDED CLASS EDGE APPLICATION Gamma Wipe SuperSorb Knitted Polyester ISO Class 3-5 Sealed Edge Critical Gamma Wipe 300 Knitted Polyester ISO Class 3-5 Sealed Edge Critical Gamma Wipe 120 Knitted Polyester ISO Class 4-5 Knife-Cut Critical Gamma Wipe 67 Nonwoven Polyester/ Cellulose ISO Class 5-8 Knife-Cut Controlled Quick Overview of Sterile Pre-Wetted Wipers WIPER MATERIAL RECOMMENDED CLASS EDGE APPLICATION Sterile Satpax HA Knitted Polyester ISO Class 3-5 Sealed Edge Critical Sterile Satpax 1200 Knitted Polyester ISO Class 4-5 Knife-Cut Critical Sterile Satpax 1000 Sterile Satpax 670 Nonwoven Polyester/ Cellulose Nonwoven Polyester/ Cellulose ISO Class 5-8 Knife-Cut Controlled ISO Class 5-8 Knife-Cut Controlled 7

8 Sterile Dry Wipers ISO Class 3-8 / EU Grade A-D BCR GAMMA WIPERS Validated sterile wipers for compliance with sterile operating procedures. Large size sheets for higher absorbency. Small packs for convenience and economy. Gamma Wipe SuperSorb Sterile MicroSeal SuperSorb Two-ply pinsonic construction with unique knit structure and pattern Fine ultrasonically sealed edges for reduced fiber contamination Ideal for wet applications and spill control Very high absorbency Gamma Wipe 300 Sterile UltraSeal 3000 Two-ply pinsonic tubular construction Patented wide sealed edge process for reduced fiber contamination High surface tear strength Very robust Gamma Wipe 120 Sterile Super Polx 1200 Knife cut edges Single layer construction Available in two sizes: 9x9 and 12x12 Economical wiper for critical applications Gamma Wipe 67 Sterile Durx % cellulose / 45% polyester hydroentangled nonwoven No binders or other chemical additives Available in two sizes: 9x9 and 12x12 High absorbency Economical General purpose PRODUCT NUMBER SIZE WIPERS/PACK PACKS/CASE Gamma Wipe SuperSorb GWSS.ST.16 30x30cm Gamma Wipe 300 GW300.ST.25 30x30cm Gamma Wipe 120 GW120.ST.15 30x30cm Gamma Wipe 120 GW120ST x23cm Gamma Wipe 67 GW67.ST.25 30x30cm Gamma Wipe 67 GW67.ST.60 30x30cm 5 60 Gamma Wipe 67 GW67ST x23cm

9 Sterile Pre-Wetted Wipers ISO Class 3-8 / EU Grade A-D BCR STERILE SATPAX WIPERS Validated sterile pre-wetted wipers, packed in re-sealable solvent resistant pouches. Ideal for cleaning critical sterile processing or aseptic environments. Safety Data Sheets (SDS) available online. Sterile Satpax HA Sterile pre-wetted ValuSeal-HA Ultrasonically sealed on 4 sides Strong, tear and abrasion resistant High absorbency Low endotoxin levels Sterile Satpax 1200 Sterile pre-wetted Super Polx 1200 Knife cut edges Single layer construction Economical wiper for critical applications Sterile Satpax 670 Sterile pre-wetted Durx % cellulose / 45% polyester hydroentangled nonwoven No secondary binders High absorbency Economical General purpose Sterile Satpax 1000 Sterile pre-wetted Durx % cellulose / 45% polyester hydroentangled nonwoven No secondary binders High absorbency Economical General purpose PRODUCT NUMBER SOLUTION SIZE WIPERS/PACK PACKS/CASE Sterile Satpax HA SSPHA % IPA / 30% DI H20 23x23cm Sterile Satpax 1200 SSP % IPA / 30% DI H20 23x23cm Sterile Satpax 670 SSP % IPA / 30% DI H20 23x23cm Sterile Satpax 1000 SSP % IPA / 30% DI H20 23x23cm

10 1.2 Dry Wipers Dry Wipers ISO Class 3-5 / EU Grade B-D / Class / Knitted Polyester - Sealed Edges KEY BENEFITS: Wipers are laundered and packed in Berkshire s ISO Class 4 cleanroom Sealed edges - wide heat seals, fine ultrasonic or laser sealed edges Double thickness for high absorbency Tear resistant for tough cleaning Sterilisable by Autoclave, Gamma or Beta Chemically compatible with IPA, Acetone and other solvents Lot tracing on each pack Vacuum and double packed Stacked or Bulk packaging MicroSeal SuperSorb Two-ply pinsonic construction with unique knit structure and pattern Fine ultrasonically sealed edges for reduced fiber contamination Ideal for wet applications and spill control Very high absorbency Choice SuperSorb Two-ply pinsonic construction with unique diamond pattern Fine ultrasonically sealed edges for reduced fiber contamination Ideal for wet applications and spill control Very high absorbency Economical alternative to the MicroSeal SuperSorb UltraSeal 3000 Two-ply pinsonic tubular construction Patented wide sealed edge process for reduced fiber contamination High surface tear strength Very robust MicroSeal 3000 Two-ply pinsonic tubular construction Fine ultrasonically sealed on 2 edges High surface tear strength Very robust 10

11 MicroSeal 1200 Fine ultrasonically sealed on 4 edges High absorbency Clean, soft and pliable edges Very low in particles and fibers MicroSeal -VP Fine ultrasonically sealed on 4 edges Very low in particles and fibers Low endotoxin levels Economical alternative to the MicroSeal 1200 ValuSeal-HA Fine ultrasonically sealed on 4 edges Strong, tear and abrasion resistant High absorbency Very low in particles and fibers ValuSeal -LP Fine ultrasonically sealed on 4 edges Strong, tear and abrasion resistant Good absorbency Very low in particles and fibers 11

12 ValuSeal 1500 Laser cut on 4 edges Lightweight High absorbency Very low in particles and fibers ValuSeal IonX Smooth knit structure Laser cut on 4 edges Lightweight Critically low in particles, fibers, ions and extractables CapSure -VP Fine ultrasonically sealed on 4 edges Patented surface treatment captures and retains particulate contamination Captures 42 times more particles than competitive (untreated) wipers Retains 93% of particles captured Super Polx SWSE Fine ultrasonically sealed on 4 edges Soft and pliable edges High absorbency Very economical Super Polx LWSE Fine ultrasonically sealed on 4 edges Lightweight Good absorbency Very economical 12

13 PRODUCT NUMBER SIZE WIPERS/PACK PACKS/CASE MicroSeal SuperSorb MSSS x23cm MicroSeal SuperSorb MSSS x30cm Choice SuperSorb CHSS x23cm Choice SuperSorb CHSS09B.14 23x23cm 75 (Bulk) 14 Choice SuperSorb CHSS x30cm Ultra-Seal 3000 US x23cm Ultra-Seal 3000 US B.8 23x23cm 100 (Bulk) 8 Ultra-Seal 3000 US x30cm Ultra-Seal 3000 US B.6 30x30cm 100 (Bulk) 6 MicroSeal 3000 MS x23cm MicroSeal 1200 MS B.10 10x10cm 600 (Bulk) 10 MicroSeal 1200 MS x23cm MicroSeal 1200 MS x30cm MicroSeal -VP MSVP x23cm MicroSeal -VP MSVP.0909B.8 23x23cm 150 (Bulk) 8 MicroSeal -VP MSVP x30cm MicroSeal -VP MSVP.1212B.14 30x30cm 75 (Bulk) 14 ValuSeal-HA VSHA x23cm ValuSeal-HA VSHA.0909B.8 23x23cm 150 (Bulk) 8 ValuSeal-HA VSHA x30cm ValuSeal-HA VSHA.1212B.14 30x30cm 75 (Bulk) 14 ValuSeal -LP VSLP x23cm ValuSeal -LP VSLP.0909B.8 23x23cm 150 (Bulk) 8 ValuSeal -LP VSLP x30cm ValuSeal -LP VSLP.1212B.14 30x30cm 75 (Bulk) 14 ValuSeal 1500 VS x23cm ValuSeal 1500 VS B.8 23x23cm 150 (Bulk) 8 ValuSeal 1500 VS x30cm ValuSeal 1500 VS B.14 30x30cm 75 (Bulk) 14 ValuSeal IonX VSI cm x ValuSeal IonX VSI.0909B.14 23cm x (Bulk) 14 CapSure -VP CPSVP x23cm CapSure -VP CPSVP.0909B.8 23x23cm 150 (Bulk) 8 CapSure -VP CPSVP x30cm CapSure -VP CPSVP.1212B.14 30x30cm 75 (Bulk) 14 Super Polx SWSE SPSWSE.0404B.10 10x10cm 600 (Bulk) 10 Super Polx SWSE SPSWSE x23cm Super Polx SWSE SPSWSE.0909B.10 23x23cm 150 (Bulk) 10 Super Polx SWSE SPSWSE x30cm Super Polx LWSE SPLWSE.0909B.14 23x23cm 150 (Bulk) 14 13

14 Dry Wipers ISO Class 4-5 / EU Grade B-D / Class / Knitted Polyester - Knife-Cut KEY BENEFITS: Wipers are laundered and packed in Berkshire s ISO Class 4 cleanroom Tear resistant for tough cleaning Sterilisable by Autoclave, Gamma or Beta Chemically compatible with IPA, Acetone and other solvents Lot tracing on each pack Vacuum packed and double packed Stacked or Bulk packaging Super Polx 1200 Very good absorbency Economical wiper for critical applications Super Polx 1200A Very good absorbency Economical alternative to the Super Polx 1200 Super Polx SW Good absorbency Very economical PRODUCT NUMBER SIZE WIPERS/PACK PACKS/CASE Super Polx 1200 S B.10 10x10cm 600 (Bulk) 10 Super Polx 1200 S x15cm 300 (Bulk) 9 Super Polx 1200 S x23cm Super Polx 1200 S B.8 23x23cm 150 (Bulk) 8 Super Polx 1200 S x30cm Super Polx 1200 S B.14 30x30cm 75 (Bulk) 14 Super Polx 1200A S1200A x23cm Super Polx 1200A S1200A.0909B.10 23x23cm 150 (Bulk) 10 Super Polx 1200A S1200A x30cm Super Polx SW SPSW x23cm Super Polx SW SPSW.0909B.10 23x23cm 150 (Bulk) 10 Super Polx SW SPSW x30cm

15 Dry Wipers ISO Class 5-8 / EU Grade B-D / Class ,000 / Knitted Polyester - Unlaundered KEY BENEFITS: Economic high volume cleaning and wipe-downs Superior tear resistance for cleaning rough surfaces and sharp edges Sterilisable by Autoclave, Gamma or Beta Chemically compatible with IPA, Acetone and other solvents Lot tracing on each pack Vacuum packed and double packed Polx 1200 High surface tear strength Good absorbency Economical PRODUCT NUMBER SIZE WIPERS/PACK PACKS/CASE Polx 1200 P x23cm Polx 1200 P x30cm Dry Wipers ISO Class 3-5 / EU Grade B-D / Class / Laundered Open-Cell Polyurethane Foam KEY BENEFITS: Very low in particles and fibers Laser cut on 4 edges Soft and non-abrasive Chemically compatible with IPA and other solvents High sorbency capacity Entraps and removes the particles PureSorb Foam Wiper Polyester-based polyurethane foam wiper 100 ppi open cell hydrophilic foam Enhanced removal of disinfecting solutions Reticulated in a non-chemical process Excellent for applying cleaning solutions to large surfaces Very high absorbency PRODUCT NUMBER SIZE WIPERS/PACK PACKS/CASE PureSorb Foam Wiper PS cm x 13cm 50 (Bulk) 20 PureSorb Foam Wiper PS cm x 23cm 50 (Bulk) 8 15

16 Dry Wipers ISO Class 4-5 / EU Grade B-D / Class / Microfiber KEY BENEFITS: Wipers are laundered and packed in Berkshire s ISO Class 4 cleanroom Fine ultrasonically sealed edges for reduced fiber contamination Ultrafine, wedge-shaped polyester and nylon filaments Tight knitted structure Smooth surface Extremely soft Chemically compatible with IPA, Acetone and other solvents MicroPolx 4000 HP Ultrafine microfiber yarn provides superior wiping efficiency Wedge-shaped fiber cross section lifts, entraps and removes particles from critical surfaces Cleans efficiently with less solvent usage compared to traditional wipers Removes oily soils with little or no solvent required Used for delicate cleaning processes High absorbency MicroPolx 2750 Ultrafine microfiber yarn provides superior wiping efficiency Wedge-shaped fiber cross section lifts, entraps and removes particles from critical surfaces Cleans efficiently with less solvent usage compared to traditional wipers Removes oily soils with little or no solvent required Designed for scratch sensitive surfaces Economical PRODUCT NUMBER SIZE WIPERS/PACK PACKS/CASE MicroPolx 4000 HP MP4000HP x23cm MicroPolx 4000 HP MP4000HP x30cm MicroPolx 2750 MPX x23cm

17 Dry Wipers ISO Class 5-8 / EU Grade B-D / Class ,000 / Nonwoven KEY BENEFITS: Low in particles and fibers Economical Very high absorbency Lot tracing on each pack Double packed High wet strength BlueSorb 750 Nonwoven polyester/cellulose blend Blue colour indicates wetness Very absorbent Sterilisable by Autoclave, Gamma or Beta Chemically compatible with common cleaning and disinfecting solutions Durx 770 Nonwoven polyester/cellulose blend Binder treatment to reduce particle and fiber generation Absorbent Sterilisable by Autoclave, Gamma or Beta Chemically compatible with common cleaning and disinfecting solutions Durx 670 Nonwoven polyester/cellulose blend Recommended for general cleaning and spill control No binders or other chemical additives Sterilisable by Autoclave, Gamma or Beta Chemically compatible with common cleaning and disinfecting solutions Durx 670-Roll Nonwoven polyester/cellulose blend Pre-perforated sheets on plastic core Economical Good upgrade from industrial wipers Ideal for grey areas and controlled environments Exsorbx % polyester, hydroentangled nonwoven Low fiber and particle generation Quickly absorbs water and solvents Works well with IPA and other solvents Prevents abrasion with its soft and pliable surface Pro-Wipe 750 Nonwoven polypropylene/cellulose blend Layer of cellulose thermally bonded between two outer layers of polypropylene Low fiber and particle generation Chemically compatible with strong solvents Excellent for cleaning scratch sensitive surfaces 17

18 Pro-Wipe % Nonwoven polypropylene Multiple layers of polypropylene thermally bonded in a quilted construction Durable and pure with a very low particle and fiber generation Chemically compatible with strong solvents and acids Ideal for equipment cleaning and spill pick up ValuClean Plus Nonwoven polyester/rayon blend Recommended for general cleaning and spill control No binders or other chemical additives Very absorbent Chemically compatible with common cleaning and disinfecting solutions PRODUCT NUMBER SIZE WIPERS/PACK PACKS/CASE BlueSorb 750 BS x10cm BlueSorb 750 BS x23cm BlueSorb 750 BS x30cm Durx 770 DR x10cm Durx 770 DR x10cm Durx 770 DR x18cm Durx 770 DR x23cm Durx 770 DR x30cm Durx 770 DR x45cm Durx 670 DR x10cm Durx 670 DR x10cm Durx 670 DR x18cm Durx 670 DR x23cm Durx 670 DR x23cm Durx 670 DR x30cm Durx 670 DR x45cm Durx 670-Roll DR R 34x38cm Exsorbx 400 ES x10cm Exsorbx 400 ES x23cm Pro-Wipe 750 PW x23cm Pro-Wipe 750 PW x30cm Pro-Wipe 880 PW x25cm Pro-Wipe 880 PW x30cm ValuClean Plus VCLP x23cm ValuClean Plus VCLP x30cm

19 Dry Wipers ISO Class 6-8 / EU Grade C-D / Class 1, ,000 / Nonwoven Lensx 90 Nonwoven rayon/hemp blend 100% biodegradable Extremely soft Ideal for cleaning delicate surfaces Nonabrasive Dry Wipers ISO Class 6-8 / EU Grade C-D / Class 1, ,000 / Woven Cotton KEY BENEFITS: Excellent strength and durability High heat resistance Excellent resistance to the build-up of electrostatic discharge in 40-60% RH environments Good absorbency Works well with IPA and other solvents Double packed Twillx % woven cotton Twill pattern and bias cut 100% biodegradable Ideal for cleaning heated surfaces Nonabrasive PRODUCT NUMBER SIZE WIPERS/PACK PACKS/CASE Lensx 90 LN x15cm Lensx 90 LN x23cm Twillx 1622 T x23cm Twillx 1622 T x30cm

20 1.3 Pre-wetted Wipers Berkshire s pre-wetted wipers are designed for both critical and controlled processes where control of flammable solvents and flammable solvent concentrations is required. A high saturation level is ideal for removing, cleaning and disinfecting residues in regulated environments. Pre-wetted with IPA and DI Water, these wipers are available in an easy, ready-to-use format. The IPA is of EU Pharmacopoeia grade. Safety Data Sheets (SDS) available online. KEY BENEFITS Minimise VOC (volatile organic compound) Consistent saturation level, same wetness every time No over-spraying or wetting of surfaces Re-sealable flexible pouches No handling or preparation costs Quick Overview of Pre-Wetted Wipers WIPER MATERIAL RECOMMENDED CLASS EDGE APPLICATION Satpax 3000 Knitted Polyester ISO Class 3-5 Sealed Edge Critical Satpax HA-R Knitted Polyester ISO Class 3-5 Sealed Edge Critical Satpax 120-R Knitted Polyester ISO Class 4-5 Knife-Cut Critical Satpax 1000 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Satpax 1000 Canister Nonwoven Polyester/Cellulose ISO Class 5-8 Pre-perforated Controlled Satpax 670 Nonwoven Polyester/Cellulose ISO Class 5-8 Knife-Cut Controlled Satpax 550 Polypropylene ISO Class 5-8 Knife-Cut Controlled 20

21 Pre-wetted Wipers BCR SatPax Wipers / Critical Process / ISO Class 3-5 / EU Grade B-D / Class Satpax 3000 Pre-wetted UltraSeal 3000 Laundered and packaged in Berkshire s ISO Class 4 cleanroom Two-ply pinsonic tubular construction Patented wide sealed edge process for reduced fiber contamination High surface tear strength Very robust Satpax HA-R Pre-wetted ValuSeal-HA Laundered and packaged in Berkshire s ISO Class 4 cleanroom Ultrasonically sealed on 4 sides Strong, tear and abrasion resistant High absorbency Very low in particles and fibers Satpax 120-R Pre-wetted Super Polx 1200 Laundered and packaged in Berkshire s ISO Class 4 cleanroom Knife cut edges Single layer construction Economical wiper for critical applications PRODUCT NUMBER SOLUTION SIZE WIPERS/PACK PACKS/CASE Satpax 3000 SPX % IPA / 30% DI H20 23x23cm Satpax HA-R SPXHAR % IPA / 30% DI H20 23x23cm Satpax 120-R SPX120R % IPA / 30% DI H20 23x23cm

22 Pre-wetted Wipers BCR SatPax Wipers / Controlled Process / ISO Class 5-8 / EU Grade B-D / Class ,000 Satpax 670 Pre-wetted Durx % cellulose / 45% polyester hydroentangled nonwoven No secondary binders High absorbency Economical General purpose Satpax 1000 Pre-wetted Durx % cellulose / 45% polyester hydroentangled nonwoven No secondary binders High absorbency Economical General purpose Satpax 1000 Canister Pre-wetted Durx % cellulose / 45% polyester hydroentangled nonwoven No secondary binders High absorbency Economical General purpose Satpax % meltblown polypropylene Low in particles and fibers No secondary binders PRODUCT NUMBER SOLUTION SIZE WIPERS/PACK PACKS/CASE Satpax 670 SPX % IPA / 30% DI H20 23x23cm Satpax 670 SPX % IPA / 30% DI H20 23x28cm Satpax 1000 SPX % IPA / 30% DI H20 23x23cm Satpax 1000 SPX % IPA / 91% DI H20 23x23cm Satpax 1000 Canister SPXC % IPA / 30% DI H20 15x23cm Satpax 1000 Refill SPXC R (Refill) 70% IPA / 30% DI H20 15x23cm Satpax 1000 Canister SPXC % IPA / 91% DI H20 15x23cm Satpax 1000 Refill SPXC R (Refill) 9% IPA / 91% DI H20 15x23cm Satpax 550 SPX % IPA / 30% DI H20 23x28cm

23 2 Mops & Accessories BCR Flat Mop Wipers BCR Flat Mop Wipers are designed to minimise and remove cleanroom contamination in a wide range of applications and are manufactured to the highest quality standards, offering consistent performance every time. Mop Wipers range from critical 100% knitted polyester to controlled process nonwoven wipers. All the wipers are measured to exactly fit the Mop Head system. Mop Wipers are disposable. More than one wiper can be attached to the mop head at a time. After mopping the area, the outer wiper can be disposed of and the remaining wipers are ready for the next mopping phase. This guarantees a fresh wiper is used for each new phase, maximising the efficiency of the cleaning. APPLICATIONS ISO Class 3-8 / EU Grade B-D / Class 1-100,000 Floors, walls and ceilings Wet or dry Quick Overview of BCR Flat Mop Wipers FLAT MOP WIPERS APPLICATION AUTOCLAVABLE GAMMA STERILISABLE PRE-WETTED MicroSeal SuperSorb Critical yes yes No Super Polx 1200A Critical yes yes No Polx 1200A Controlled yes yes No Durx 670 Controlled yes yes No Satpax 670 Controlled No yes Yes PRODUCT NUMBER SIZE WIPERS/PACK PACKS/CASE MicroSeal SuperSorb MSSS x30cm MicroSeal SuperSorb MSSS x60cm Super Polx 1200A S1200A x23cm Polx 1200A PL1200A x23cm Durx 670 DR x30cm Durx 670 DR x60cm Durx 670 DR x23cm Satpax % IPA / 30% DI H20 SPX x23cm Satpax % IPA / 50% DI H20 SPX x23cm

24 BCR Flat Mop Heads Berkshire s Flat Mop Head is light and easy to manoeuvre, even with wet wipers attached. The head is made of high quality aluminium, which is clean, light and durable. The stainless steel springs hold up to five mop wipers in place and are very easy to operate. The bottom of the mop is smooth and has no lines or grooves where bacteria or other contamination can settle. BCR Flat Mop Heads can be autoclaved for use in sterile applications. APPLICATIONS ISO Class 3-8 / EU Grade B-D / Class 1-100,000 Floors, walls and ceilings BCR Flat Mop Heads & Telescopic Handle, PRODUCT NUMBER FIXING MATERIAL SIZE PIECE/PACK PACKS/CASE Flat Mop Head 1 FLATMOPHEAD1AP Plastic "eyes"* Flat Mop Head 2 FLATMOPHEAD2AM Metal Springs Flat Mop Head 3 FLATMOPHEAD3AP Plastic "eyes"* Telecopic Handle HANDLE.FM.TELE.180 N/A *Eyes are not autoclavable Lightweight anodised aluminum Lightweight anodised aluminum Lightweight anodised aluminum Lightweight anodised aluminum 9x28cm x58cm x58cm cm

25 BCR Folding Flat Mop Covers Two different folding flat mop covers are available to handle a variety of cleaning tasks. An absorbent 100% knitted polyester outer cover combined with a 100% rayon nonwoven inner layer as well as an irradiated polyester cellulose blend nonwoven cover. The Folding Flat Mop Covers are designed for the capture and removal of contaminants during the cleaning process on uneven as well as smooth surfaces. APPLICATIONS ISO Class 4-8, EU Grade B-D / Class ,000 Floors, walls and ceilings Dry, compatible with a wide range of solvents PRODUCT NUMBER MATERIAL SIZE MOPS/PACK PACKS/CASE Flat Mop Cover 1 (Irradiated) FMC1IR.10 Nonwoven Polyester/Cellulose outer cover - Rayon inner layer 13x40cm Flat Mop Cover 2 FMC2.10 Knitted polyester outer cover - Rayon inner layer 13x39cm BCR Folding Flat Mop System Efficient cleaning of floors, walls and other large surfaces is critical to the overall cleanliness of the production environment. The BCR Folding Flat Mop System replicates the most effective way to clean a surface. It is easy to use and efficient. APPLICATIONS ISO Class 4-8 / EU Grade B-D / Class ,000 Floors, walls and ceilings PRODUCT NUMBER FIXING SIZE PIECE/PACK PACKS/CASE Folded Flat Mop FFM.10 Click to lock 10x40cm 1 10 Telecopic Handle HANDLE.FM.TELE.180 N/A cm

26 3 Isolator Cleaning Tool BCR EasyClean 360 Isolator Cleaning Tool The EasyClean 360 System includes a lightweight, manoeuvrable cleaning tool and easy-to-use, laundered polyester knitted and nonwoven covers. The padded knitted cover and rounded edges of the mop head ensure the tool does not scratch or damage surfaces. The system provides efficient cleaning of isolators, biological safety cabinets, laminar flow hoods and other mini-environments that are critical to the quality and purity of compounded products. APPLICATIONS ISO Class 3-8 / EU Grade A-C / Class 1-100,000 Isolators, biological safety cabinets, laminar flow hoods and other mini-environments KEY BENEFITS: Durable, mirror finish, stainless steel mop head swivels 360 for easy handling Head can be locked for 180 swivel when desired 10cm x 18cm triangular head shape allows for improved access in tight corners Light-weight anodised aluminum handles provided in 2 lengths - 35cm and 60cm Quick connect handle mechanism for easy attachment after pass-through Sterilisable by Autoclave or Gamma Isolator Cleaning Tool, PRODUCT NUMBER SIZE SIZE HANDLES TOOL/CASE EasyClean 360 Isolator Cleaning Tool EC360.ICT.1 10x18cm Triangular 35cm & 60cm 1 Head & 2 Handles Isolator Cleaning Tool Mops, PRODUCT NUMBER MATERIAL COVERS/PACK PACKS/CASE EasyClean 360 Elastic Isolator Cleaning Tool Covers EC360.EC.6 Super Polx elastic covers & 1 padded cover/pack 6 packs/case Sterile EasyClean 360 Elastic Isolator Cleaning Tool Covers EC360.ECST.20 (Sterile) Super Polx elastic covers & 1 padded cover/pack, 4 packs/cracker pack 5 cracker packs/case EasyClean 360 Nonwoven Isolator Cleaning Tool Covers EC360.NW.40 Nonwoven Polyester/ Cellulose 5 covers/pack, 4 packs/ bag 10 bags/case Irradiated EasyClean 360 Nonwoven Isolator Cleaning Tool Covers EC360.NW.1IR (Irradiated) Nonwoven Polyester/ Cellulose 1 cover/pack, 20 packs/bag 10 bags/case 26

27 4 Face masks BCR GI Face Masks People are the greatest source of contamination and breathing or speaking are among the most contaminating activities. Masks play a critical role in minimising such contamination. Berkshire masks are manufactured to the highest quality standards, offering consistent performance every time. Our masks are made with three layers, combining maximum comfort for the wearer while ensuring maximum protection for process. All the materials used are low in particles and fibers but also free of surfactants and chemicals. APPLICATIONS KEY BENEFITS Individually packed Gamma Irradiated with a minimum dose of 25kGy Wide sizes available Comfortable Ultrasonic bonding to reduce contamination and outgassing Certificates of Irradiation available online, by lot number at Easy to breathe ISO Class 4-8 / EU Grade A-D Sterile applications Quick Overview of BCR GI Face Masks MODEL BCR GI FACE MASK WITH EARLOOPS BCR GI FACE MASK WITH HEAD TIES Inner facing Viscose/polyester Viscose/polyester Outer facing Viscose/polyester Viscose/polyester Filter media Polyester Polyester Nose piece Enclosed Aluminium Enclosed Aluminium Masks Sizes 180x90mm 180x90mm 210x90mm 210x90mm PRODUCT NUMBER SIZE MASKS/PACK PACKS/BAG BAGS/CASE BCR GI Face Mask with Earloops BM180GIE10 180x90mm BCR GI Face Mask with Earloops BM210GIE10 210x90mm BCR GI Face Mask with Head Ties BM180GIT10 180x90mm BCR GI Face Mask with Head Ties BM210GIT10 210x90mm

28 BCR Face Masks Berkshire s face masks minimise human contamination by providing very high levels of particle and bacterial filtration. The 210mm wide masks provide extra face coverage and protection. Berkshire s BM 1 and BM 1W are both individually packed and contain a clip for linking the earloops behind the head when desired. KEY BENEFITS Comfortable Wide sizes available Easy to breathe APPLICATIONS ISO Class 4-8 / EU Grade B-D / Class ,000 Quick Overview of BCR Face Masks MODEL BM 1 & BM 1WIDE MASK CE-3PEL.W BM.1FWE.50 MASK CE-3P4T.15 Inner facing Polypropylene Polypropylene Polypropylene Polypropylene Outer facing Polypropylene Polymeric net Polyethylene Polymeric net Filter media Polypropylene Polypropylene Polypropylene Polypropylene Material Loop Polyurethane Earloops Polyurethane Earloops Knitted Nylon earloops Polypropylene Head Ties Nose piece PVC coated wire PVC coated wire PVC coated wire PVC coated wire Masks Sizes 180x90mm 210x90mm 180x90mm 180x90mm 210x90mm PRODUCT NUMBER SIZE MASKS/PACK PACKS/BAG BAGS/CASE BCR 3-Layer with Polyurethane Earloops BCR 3-Layer with Polyurethane Earloops BCR 3-Layer with Polyurethane Earloops BCR 3-Layer with Knitted Nylon Earloops BCR 3-Layer with Polypropylene Head Ties BM x90mm 1 (with clip) BM.IW x90mm 1 (with clip) MASK CE-3PEL.W 210x90mm BM.1FWE x90mm MASK CE-3P4T x90mm

29 5 Glove Liners BCR Glove Liners Comfortable hands are critical to an operator s productivity. Gloved hands free of perspiration and allergies are also vital to an operator s health and safety. BCR Glove Liners were developed to provide this comfort. Worn underneath latex, vinyl or nitrile gloves, BCR Glove Liners provide a space between skin and glove that allows the hands to breath. The gloves are ambidextrous. Each glove size has a coloured cuff for easy stock control. The half-finger versions are ideal for operators who need to retain maximum dexterity and fingertip sensitivity. BCR Glove Liners are manufactured to the highest standards, offering consistent performance every time. The liners are made out of 100% continuous filament polyester, laundered to reduce particle and fiber release and and are available in 2 sizes to maximise comfort. There are no seams on the gloves that could unravel and cause contamination. They are medium weight and are soft and comfortable to wear for long periods. The liners can be re-laundered and used again. KEY BENEFITS Soft and comfortable Full and half-finger options Large and regular sizes Seamless no-run construction Ambidextrous Sterilisable by Autoclave or Beta The BCR Glove Liners are suitable in any ISO class cleanroom when worn underneath nitrile, latex or vinyl gloves. PRODUCT NUMBER SIZE PAIRS/PACK PACKS/CASE Polyester Half-Finger BGL2.20R Regular Polyester Half-Finger BGL2.20L Large Polyester Full-Finger BGL3.20R Regular Polyester Full-Finger BGL3.20L Large

30 6 Documentation Systems BCR Bond Cleanroom Paper BCR Bond cleanroom paper is made with the purest quality cellulose from specially selected forests and is precisely coated to minimise particle and fiber release. BCR Bond comes in a variety of weights and colours, from heavy weight 104g paper for extra tear resistance and opacity to allow double sided printing, to lighter weight 68g for economy. APPLICATIONS NON-STANDARD OPTIONS Berkshire is a flexible manufacturer and we are always willing to consider requests for non-standard products Sizes: Berkshire can supply non-standard sizes to your specification Format: Berkshire can supply pre-punched paper Packaging: Non-standard packaging can be provided ISO Class 3-7 / EU Grade B-D / Class 1-10,000 Writing, copying and printing KEY BENEFITS Purest cellulose to minimise contamination Specialised coating to reduce particles, fibers and microorganisms Smooth surface reduces particle contamination Compatible with all standard copiers and printers Retains ink from copiers and printers to reduce smudging Available in 3 different weights (104gr, 85gr and 68gr) Double packed for cleanliness Sterilisable by Autoclave* and Gamma * Blue coloured paper is not autoclavable PRODUCT NUMBER SIZE SHEETS/PACK PACKS/CASE BCR Bond 104g/m² White B104.A3.WH.250/5 A Blue B104.A3.BL.250/5 A White B104.A4.WH.250/10 A Blue B104.A4.BL.250/10 A White B104.A5.WH.250/20 A Blue B104.A5.BL.250/20 A

31 PRODUCT NUMBER SIZE SHEETS/PACK PACKS/CASE BCR Bond 85g/m² White B85.A3.WH.250/5 A Blue B85.A3.BL.250/5 A White B85.A4.WH.250/10 A Blue B85.A4.BL.250/10 A Pink B85.A4.PK.250/10 A Yellow B85.A4.YL.250/10 A Green B85.A4.GN.250/10 A White B85.A5.WH.250/20 A Blue B85.A5.BL.250/20 A BCR Bond 68g/m² White B68.A3.WH.250/5 A Blue B68.A3.BL.250/5 A White B68.A4.WH.250/10 A Blue B68.A4.BL.250/10 A White B68.A5.WH.250/20 A Blue B68.A5.BL.250/20 A EcoBond Recyclable Cleanroom Paper EcoBond is a fully recyclable version of BCR Bond cleanroom paper. EcoBond is made from the same pure sources of cellulose as our standard BCR Bond cleanroom paper. APPLICATIONS ISO Class 3-7 / EU Grade B-D / Class 1-10,000 Writing, copying and printing KEY BENEFITS 100% virgin cellulose Low in particles and fibers Smooth surface reduces particle contamination Compatible with all standard copiers and printers* Lot number for tracing Double packed for cleanliness Sterilisable by Autoclave** and Gamma * Not recommended for use with inkjet printers ** Blue coloured paper is not autoclavable PRODUCT NUMBER SIZE SHEETS/PACK PACKS/CASE EcoBond 85g/m² White ECO85.A4.WH A Blue ECO85.A4.BL A

32 BCR CleaNotes BCR CleaNotes are made with 104g/m² weight cleanroom white bond paper. A special adhesive backing allows CleaNotes to easily stick to any surface without leaving residues when the note is removed. APPLICATIONS ISO Class 3-7 / EU Grade B-D / Class 1-10,000 Small notes and reminders KEY BENEFITS 104g/m² weight cleanroom white bond paper Low in particles and fibers Smooth surface reduces particle contamination Adhesive designed specifically not to leave unwanted residues behind Silicone free PRODUCT NUMBER SIZE SHEETS/PACK PACKS/CASE BCR CleaNotes BCN x8cm BCR MyNotes Notebooks BCR MyNotes Notebooks are made with Berkshire s BCR Bond cleanroom paper to minimise particle contamination. They are made with a spiral binding for easy use. APPLICATIONS ISO Class 3-7 / EU Grade B-D / Class 1-10,000 Note taking, data recording KEY BENEFITS 85g/m² weight BCR Bond Purest cellulose to minimise contamination Low in particles and fibers Smooth surface reduces particle contamination Lot number for tracing Double packed for cleanliness PRODUCT NUMBER SIZE SHEETS/BOOK BOOKS/PACK PACKS/CASE BCR MyNotes A4 CR (Lined) MNBK-A4.CR A BCR MyNotes A4 Grid (1/4 Inch Grid) MNBK-A4.GRID A BCR MyNotes A5 CR (Lined) MNBK-A5.CR A BCR MyNotes A5 Grid (1/4 Inch Grid) MNBK-A5.GRID A BCR MyNotes Memo CR (Lined) MNBK-MEMO.CR Memo

33 7 Swabs Berkshire s Lab-Tips Cleanroom swabs are designed to minimise and remove cleanroom contamination in a wide range of applications. The wide variety of handle lengths and tip shapes ensures the most difficult spots can be reached and cleaned. Both tips and handles are made with the highest quality cleanroom materials to minimise particle and fiber contamination. APPLICATIONS Cleaning validation and precision cleaning KNITTED SWABS NUMBER MATERIAL TIP SIZE HANDLE SIZE TOTAL SIZE SWABS/PACK PACKS/CASE LTP125 LTP125.5 Polyester 25mm 100mm 125mm LTP70F LTP70F.20 Polyester 11mm 59mm 70mm LTP70R LTP70R.20 Polyester 11mm 59mm 70mm LTP1465 LTP Polyester 17mm 145mm 162mm

34 NONWOVEN SWABS NUMBER MATERIAL TIP SIZE HANDLE SIZE TOTAL SIZE SWABS/PACK PACKS/CASE LTN1465 LTN Polyester 17mm 145mm 162mm LTN70F LTN70F.20 Polyester 11mm 59mm 70mm LT LT Abaca / Wood Pulp Blend (Labx 170) 21mm 46mm 67mm LT LT Polyester/Cellulose (Durx 670) 20mm 47mm 67mm FOAM SWABS NUMBER MATERIAL TIP SIZE HANDLE SIZE TOTAL SIZE SWABS/PACK PACKS/CASE LTC125 LTC125.5 Polyurethane Foam, Closed-Cell 25mm 100mm 125mm LT LT Polyurethane Foam, Open-Cell 25mm 100mm 125mm LTO1465 LTO Polyurethane Foam, Open-Cell 17mm 145mm 162mm LT LT Polyurethane Foam, Open-Cell 21mm 49mm 70mm LTA03163 LTA Polyurethane Foam, Open-Cell 13mm 60mm 73mm LTO70P LTO70P.20 Polyurethane Foam, Open-Cell 20mm 50mm 70mm

35 POLYESTER SWAB NUMBER MATERIAL TIP SIZE HANDLE SIZE TOTAL SIZE SWABS/PACK PACKS/CASE BCS 100 BCS100 Polyester 13mm 76mm 89mm NYLON SWABS NUMBER MATERIAL TIP SIZE HANDLE SIZE TOTAL SIZE SWABS/PACK PACKS/CASE BCS 300 BCS300 Nylon 13mm 76mm 89mm BCS 400 BCS400 Nylon 13mm 76mm 89mm TOC/SAMPLING SWABS NUMBER MATERIAL TIP SIZE HANDLE SIZE TOTAL SIZE SWABS/PACK PACKS/CASE LTP125TOC LTP125TOC.25 Knitted Polyester 25mm 100mm 125mm LTP125S LTP125S.25 Knitted Polyester 25mm 100mm 125mm ESD SWABS NUMBER MATERIAL TIP SIZE HANDLE SIZE TOTAL SIZE SWABS/PACK PACKS/CASE LTP1465ESD10 LTP1465ESD10 Knitted Polyester 17mm 145mm 162mm LTO70PESD20 LTO70PESD20 Polyurethane Foam, Open-Cell 20mm 50mm 70mm LTO70RESD20 LTO70RESD20 Polyurethane Foam, Open-Cell 12mm 58mm 70mm

36 Sterilisation Validation Process DEFITNITIONS Bioburden: Population of viable microorganisms on a product. Sterility Assurance Level (SAL): Probability of a viable organism being present on a product unit after sterilisation. Expressed as 10 n. A SAL of 10 6 is the probability of one non-sterile unit in one million. Dosimeter: Device which can be used to measure the absorbed dose in a given material. ANSI/AAMI/ISO BIOBURDEN STUDY 3 lots/10 samples/lot Determines inherent level of bioburden. PACKAGING QUALIFICATION BIOBURDEN RECOVERY FACTOR BACTERIOSTASIS/FUNGISTASIS TESTING STERILITY VALIDATION DOSE 100 units irradiated at a sublethal dose. Dose is based on bioburden level and a SAL of STERILITY TESTING 100 units from above step tested for sterility. To continue must have 2 positives. CERTIFICATE OF STERILITY IRRADIATION Product is irradiated at a predetermined minimum dose. The actual dose is verified with dosimeters. CERTIFICATE OF PROCESSING ANSI/AAMI/ISO METHOD 1 OR VD MAX 25 AUDITS Audits performed quarterly to check bioburden and sterility at the validation dose. PACKAGING VALIDATION 36

37 WIPER TEST METHODS BERKSHIRE tests wiper properties identified by contamination control professionals as most critical. The test methods we employ are vital to product development and quality assurance. All test methods are based on the Institute of Environmental Sciences and Technology (IEST) standard, IEST-RP-CC004.3: Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments. The following are brief descriptions of Berkshire s Wiper Tests: CLEANLINESS Fibers A wiper is washed in water using a biaxial shaker for five minutes. The fibers released into the water are filtered onto a membrane and counted microscopically. The results are expressed as fibers 100µm per square centimeter of wiper. Particle Generation / Biaxial Shake Test A wiper is washed in water using a biaxial shaker for five minutes. A liquid-borne particle counter then tallies the particles released into the water. By dividing the total number of particles released by the area of the wiper, the results are expressed as particles 0.5µm per square centimeter of wiper. ABSORBENCY Capacity A sample of wiper material is saturated with as much fluid as it can hold. After one minute, the material is weighed, and results are expressed in milliliters of fluid per square meter. Efficiency This calculation indicates how well a material absorbs, relative to others. Results, expressed in milliliters of liquid per gram of material, assisting in comparing one raw material with another. Rate This test is a measurement of the time it takes a wiper to absorb half the total liquid it can hold. Results are expressed in seconds. PURITY Non-Volatile Residue Berkshire generates non-volatile residue data, using both deionised water and 2-Propanol. Results are expressed in grams of extractables per square meter of wiper, which is a useful guide to relative purity of wipers. Metallic Ions Ions are extracted in deionised water and quantitatively analysed by Ion Chromatography. Results are stated in parts per million (ppm). 37

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