How a Contamination Control Program Directly Affects ... · How a Contamination Control Program...

1/

How a Contamination Control Program

Directly Affects Product Sterility

Jim Polarine

Sr. Technical Service Manager

Aaron Mertens

Technical Service Specialist

October 5, 2017

2/Copyright © 2017 STERIS Corporations. All Rights Reserved.

Introduction

Jim Polarine

• Senior Technical Service Manager

• STERIS Corporation | Life Sciences

• Mobile: 314-616-9931

• E-Mail: [email protected]

• Web: www.sterislifesciences.com

STERIS Technical Services

mailto:[email protected]

http://www.sterislifesciences.com/


Introduction

Aaron Mertens

• Technical Service Specialist

• STERIS Corporation | Life Sciences

• Mobile: 440-530-0060

• E-Mail: [email protected]

• Web: www.sterislifesciences.com

STERIS Technical Services


http://www.sterislifesciences.com/


Outline

How a Contamination Control Program Directly

Affects Product Sterility

• Deinococcus Contamination Case Study

• Fungal Spore Contamination Case Study

• Contamination Sources

• Protection of Critical Equipment

• Material Properties

5/

Deinococcus Contamination

Case Study


Medical Device Company

• Failing Bioburden Testing on Surgical Light

Covers and Camera Cases

• Visited the site – Cardboard

– Plywood

– Poor Gowning Practices

– Poor Cleanroom Behavior Practices

– Performed EM and Site Audit

– Solution• Move from Gamma Irradiation to ETO


Covers for Surgical Lights

and Camera Cases


Deinococcus


Deinococcus

10/

Fungal Spore Contamination

Case Study


Aspergillus

• ISO-5 Cleanroom

– Source

• High Impingement Spraying Device

• Broken Pipes

• HVAC Shut Down

• Exceeding Limits in ISO-7 areas

– Dock Doors proximal to ISO-7

cleanroom

– Storage room with limited control

– No limits for mold spores (Establish

Limits)

– Limited control for incoming and

outgoing items


High Pressure

Impingement Sprayers

Holes

in Walls


Courtesy Dan Klein

Aspergillus brasiliensis


Aspergillus brasiliensis

Courtesy Bruce Ritts


Courtesy Dan Klein

Cleanroom Fungi

16/

Contamination Sources


Contamination Sources

Facility• Poor design

• Aging facility

• Maintenance

• Cleaning and

disinfection

People• Gowning rooms

• Attire (clothing, shoe covers,

hoods, face masks, goggles, etc)

• Conduct

• Standard Operating Procedures

Materials• Pass through sterilizers

(autoclaves, dry heat ovens,

depyrogenation tunnels, etc.)

• Decontamination chambers (EO,

VHP, UV, etc.)

• Material handling airlocks

18/

Protection of Critical Equipment


Equipment Protection


Sterilization Wrapping


Equipment Protection


Tyvek® Material Properties

• Designed to fit all types and sizes of equipment

• No shape or size limitations

• Conforms to complicated shapes

• Elasticized, drawstring and heat seal possibilities

• Resistant to tearing and puncture

• Easy to remove without cutting or tools

• Very low particulate generation

• Excellent microbial barrier

• Steam penetration across entire surface

• Hydrophobic – no moisture retained in material

• Manufactured and processed in cleanroom


Tyvek Microbial Barrier

• ASTM F1608-00 (Reapproved 2004), “Standard Test Method for

Microbial Ranking of Porous Packing Materials (Exposure

Chamber Method)”

• Aerosol challenge to determine the passage of airborne bacteria

(Bacillus atrophaeus, ATCC#9372)

Sample Material Control Colony

Forming Units

(cfu)

Average Result

(cfu)

Log Reduction

Value (LRV)

Tyvek® 1073B 1.3 x 107 6.1 x 102 4.32

Tyvek® 1422A 1.5 x 107 5.4 x 102 4.45

BHD Blue Wrap 1.3 x 107 8.0 x 104 2.21

Kraft Paper 1.4 x 107 1.1 x 105 2.11

• The test results indicate that Tyvek 1073B and Tyvek 1422A are

greater than 99.99% effective at spore retention.


Material Imaging

Blue Paper

Paper Pouch

Tyvek 1422A

Tyvek 1073B



Material Comparison

Paper Pouch Tyvek 1073B


Number of Layers

Frayed Threads / Fibers

Cut Edges


Material Comparison

Blue Wrap Tyvek 1422A


Spacing between Fibers

Compressed Structure

Cut Edges


Conclusion

How a Contamination Control Program Directly

Affects Product Sterility

• Cleanroom contamination happens!

• Case Studies and recommended investigation /

remediation

• Other contamination sources

• Critical equipment protection

• Tyvek material versus cellulous based material


Industry References

• USP 40 <1072> Disinfectants and Antiseptics

• Annex 1 (2008) and MHRA Orange Guide (2015)

• FDA Aseptic Processing Guide (2004)

• FDA, MHRA, HPRA, CFDA, ANSM, ANVISA, & EMA Expectations

• Industry Articles (Ex. Scott Sutton, Jose Martinez, Tim Sandle, Richard Prince,

Rebecca Smith, Jeanne Moldenhauer)

• PDA Cleaning and Disinfection TR No. 70 (October, 2015)

• PDA TR No. 69 on Biofilms (2015)

• The CDC Handbook - A Guide to Cleaning & Disinfecting Cleanrooms (Tim Sandle

2016)

• A Guide to Disinfectants and their use in the Pharmaceutical Industry (Pharmig 2006)

• USP 40 <1116> Microbiological Control and Monitoring of Aseptic Processing

Environments

• USP 40 <1115> Bioburden Control of Non-Sterile Drug Substances and Products

• PIC/S Guide to Good Practices for the Preparation of Medicinal Products in

Healthcare Establishments (2014)

• WHO Annex 6

• PHSS Technical Monograph #20 “Bio-contamination characterization, control,

monitoring and deviation management in controlled/GMP classified areas


Acknowledgements

Thank you audience!

STERIS Life Sciences

• Dan Klein – Research and Development Microbiology

• Bruce Ritts – Scanning Electron Microscope

• Area Sales Representatives

• Technical Services Group – past and present

30/

Thank you for your attention!

[email protected]

[email protected]

How a Contamination Control Program

Directly Affects Product Sterility



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