Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

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Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier

Transcript of Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Page 1: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterilized, Validated, Documented and

Pyrogen Tested WipersOlivier Gautier

Page 2: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Agenda

· Sterile Wiper Benefits

· Sterile Wiper Applications

· Sterile Products

· Sterilization Process

· Sterility Validation Process and Auditing

· Documentation

Page 3: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterile Wiper Benefits

· Integrity of cleanroom is maintained

· Low levels of releasable particles and fibers

· Bags are solvent-safe for wipedown

· Terminally sterilized by gamma irradiation

· Sterility validated and audited

· Each inner bag is lot and expiration date coded

· Irradiation indicator dot on each case

· Certificates of Irradiation and Compliance are attached to each case

· Validated shelf life (3 years)

Page 4: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterile Wiper Applications

· Cleaning aseptic environments

· Floor, walls and ceiling

· Cleaning equipment and environmental surfaces in sterile environment (Class A/B)

· Process equipment, isolators, RABS

· Applying cleaning solutions and disinfectants

· Spill control

· Final wipedown after disinfection

· Wipedown of articles in pass-through

· Wiping gloved hands

Page 5: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterile Products

·Dry wipers

·Pre-wetted wipers

·Mop wipers and covers

·Swabs

· IPA / Ethanol

Page 6: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterilization Process

· Gamma Irradiation

· Electron Beam

· Steam Autoclaving

· VHP

Page 7: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterilization Process

Sterile & Validated Wipers

· Manufactured in cleanroom environment

· Controlled bioburden

· Double or triple bagged in cleanroom packaging

· Allows easy entry into aseptic environment

· Package integrity tested

· Validated

· Fully documented in validation package

Autoclaved Wipers

· Re-bagging of product is needed

· Environment control?

· Cleanroom bags quality?

· Handling issues?

· Potential contamination?

· Extra time needed

· Autoclave cycle to validate

· QC Testing

· Microbiological testing

· Documentation to establish

Page 8: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterilization Process

Gamma Irradiation:

·More penetrating power than E-Beam

·Relatively easy process to validate

·Leaves no residues from treatment

·Compatible with many materials and solutions

·Gamma irradiation shows endotoxin level reduction to a greater extend than E-Beam irradiation

· Bacterial endotoxins or pyrogens are fever-causing materials from the outer cell membranes of Gram-negative bacteria

Page 9: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterilization Process

Dose vs. Depth Comparison of E-Beam and Gamma Sterilization

Reid. B.D., “Gamma Processing Technology: An Alternative Technology for Terminal Sterilization of Parenterals,” PDA Journal of Pharmaceutical Science & Technology, Vol. 49, No. 2, 1995, pp 83-89

Page 10: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterilization Process

Effects of Gamma Rays and Accelerated Electrons on Endotoxins (e. Colli on polystyrene)

Guyomard, S., V. Goury, J. Laizier and J.C. Darbord, “Defining of the Pyrogenic Assurance Level (PAL) or Irradiated Medical Devices, “International Journal of Pharmaceuticals, Vol. 40, 1987, pp 173-174

Page 11: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterility Validation Process and Auditing

· Follow AAMI Guidelines (Association for the Advancement of Medical Instrumentation)

· To assure a 10-6 sterility assurance level (SAL)

· Validation

· Determine bioburden

· Determine gamma irradiation dose and subprocess dose

· Test sterility after irradiating at subprocess levels

· Quarterly auditing

· Determine bioburden

· Test sterility after irradiating at subprocess levels

Page 12: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterility Validation Process and Auditing

Validation process

·Bioburden – Determination (Step 1)

· 10 wipers of 3 different lots are tested to quantify the number of CFU (Colony Forming Units) per wiper

· Recovery – Determination (Step 2)

· Repeated extractions of 3 wipers to determine the total CFU

· The bioburden data are corrected for this extraction efficiency

Page 13: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterility Validation Process and Auditing

Validation process

·Dose (Step 3)

· Gamma irradiation from a Cobal-60 source

· Dose is chosen to predict allowing less than a one in a million probability of any surviving CFU on the item

· Sterility Assurance Level (SAL) = 1 ppm

Page 14: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterility Validation Process and Auditing

Validation process

·Sub-Process Dose Validation (Step 4)

· This validation is done by irradiating with an appropriately lower dose, such that there is a 1/100 probability than any organisms can survive on an item, then testing 100 wipers so irradiated for sterility.

· AAMI indicates that if two or fewer items of the 100 are non-sterile, the dose is validated. Routinely, all 100 are sterile.

Page 15: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterility Validation Process and Auditing

Validation process

·Irradiation (Step 5)

· Monitored with dosimeters

· For every irradiated lot a Certificate of Processing (CoI)

Page 16: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterility Validation Process and Auditing

Validation process

·Documentation (Step 6)

· Certificate of Irradiation or Processing (CoI)

· Certificate of Compliance (CoC)

· Certificate of Analysis (CoA)

· Supplier audits (Step 7)

Page 17: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterility Validation Process and Auditing

· Audit Process Flow

Test Results Recorded

Bioburden Testing

Test Results Recorded

Sterility Testing

Sub-dose Irrad iation

Product Released for Sale

Certificate of Processing

Sterigenics Irradation

Product ManufacturedNon-irrad iated

Page 18: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Sterility Validation Process and Auditing

Pyrogens or Endotoxins (Step 8)·Toxins from killed gram-negative bacteria·Allowable limit of endotoxins in human and animal parenteral drugs, biological and medical devices are established by the FDA

· Match USP 23 supplement 1 <161> (United State Pharmacopeia)

· Limits in parenteral: less than 20 endotoxin units per device (< 20 EU/device)

· Removing is extremely difficult prevention (bioburden)

· Measuring of endotoxins with LAL-testing

Page 19: Sterilized, Validated, Documented and Pyrogen Tested Wipers Olivier Gautier.

Documentation

Full Validated and Documented Package (Step 9) ·Product Technical Data Sheet·TechNote·Packaging Integrity Test·All Certificates (CoI, CoC, CoA)·Sterility Validation Test and Control

· Bioburden test on wiper materials (CFU)· Sterility Assurance Test· Bacterial Endotoxins or Pyrogens