1. BioClean BarrierPlus™ Sterile Sleeve & Gauntlet Range Richard Bryant

2. Nitritex Ltd are in complete control of the manufacturing process… Dipping & Drying Quality Testing Packing Washing & Drying

3. Flow Diagram of Production Process for Nitrile

4. BioClean BarrierPlus™ Features  ISO Class 4 compatible  Low levels of particulates  Accelerator-free nitrile  Excellent ESD properties  Cat 3 - Complex Design PPE  Chemical resistant including a selection of commonly-used chemotherapy drugs  Cleanroom compatible EasyTear™ packaging

5. BioClean BarrierPlus™ Features  Each gauntlet visually inspected on five separate occasions  Each gauntlet is subjected to water and air pressure testing  Each gauntlet is 100% free from pinholes

6. BioClean BarrierPlus™ Features  Washed in deionised water to remove any particles  Dried in a ISO Class 4 controlled environment

7. BioClean BarrierPlus™ Features  Packed in an ISO Class 4 cleanroom  100% inspected and air tight test before packing  Fully validated SAL 10 -6  Triple bagged

8. BioClean BarrierPlus™ Features  Packed in a white polyethylene Correx box  Two Correx boxes per carton  Reduces the risk of any particulates being generated

9. Sterile Gauntlets – S-BBNG  Available in lengths of up to 840mm (33”)  To fit port sizes from 150mm to 300mm (6.0” to 12”)

10. Sterile Sleeves – S-BBNS0  Available in lengths of up to 660mm (26”)  To fit port sizes from 150mm to 300mm (6.0” to 12”)  Cuff ring diameter of 90mm (3.5”)  Sleeves will fit the majority of available cuff ring systems

11. Sterile Mittens – S-BBNM  Uniquely designed for RABS, where interventions are rare and access speed is critical  Cost effective alternative to gauntlets  Available in lengths of up to 840mm (33”)  To fit port sizes from 230mm to 265mm (9” to 10.5”)

12. Frequently Asked Questions…  Are they single use or reusable? Can be single use or reusable depending on the end-users SOP  If reusable, how many times can they be reused? Depends on the SOP and chemicals used, and the sanitizing process  Can the Nitrile S-BBNG be autoclaved? Yes. We have successfully run 15 cycles at 121º for 30 min intervals  Are they compatible with VHP? Yes. How many exposures depends on end users unique H 2 O 2 protocol  Are the S-BBNG, S-BBNM, S-BBNS0 available in non-sterile? Yes however; non-sterile would reduce price only marginally so we recommend taking the sterile as the default option

13. Key Features & Benefits BarrierPlus™ products are:  Packed for use EU GMP Grade A areas  Fully validated for sterility  ISO Class 4 processed & packed  Extensively tested against chemo drugs (ASTM D6978-05 standard)  Batch Particle Testing for all BarrierPlus™ products  Can be order in small quantities and have them shipped with other BioClean™ quality branded products

14. ASTM D6978-05 Test Results

15. LPC Batch Test Results

16. EN 388 Test Results

17. Full Sterility Validation

18. Thank you for your attention