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SELECTING AND MANAGING CONTRACT STERILIZERS AND TESTING LABORATORIES. Pacific BioLabs Inc. (510) 964-9000 info@PacificBioLabs.com. CONTRACT STERILIZERS.

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Selecting and managing contract sterilizers and testing laboratories

SELECTING AND MANAGING CONTRACT STERILIZERS AND TESTING LABORATORIES

Pacific BioLabs Inc.

(510) 964-9000

info@PacificBioLabs.com


Contract sterilizers
CONTRACT STERILIZERS LABORATORIES

  • Written agreement between the contract sterilizer and the device manufacturer is required by 21 CFR- 801-150(e), Medical Devices, processing, labeling or repacking


Written agreement must include
WRITTEN AGREEMENT MUST INCLUDE: LABORATORIES

  • Instructions for maintaining proper records

  • Acknowledgement that the device is non-sterile and awaiting processing

  • Detailed specifications for the sterilization process

  • Division of responsibilities


Division of responsibility
DIVISION OF RESPONSIBILITY LABORATORIES

  • The device manufacturer is ultimately responsible for the sterility of its products

  • The contract sterilizer is responsible for a quality control system for steps under its control

  • Therefore, ……..


Responsibilities of manufacturer
RESPONSIBILITIES OF MANUFACTURER LABORATORIES

  • Ensure devices are sterile by confirming quality control system of contractor

  • Validation of the process

  • Ensure process controls are appropriate

  • Maintain records of specification & evidence they were followed

  • Product release


Responsibilities of contract sterilizer
RESPONSIBILITIES OF LABORATORIESCONTRACT STERILIZER

  • All requirements of the quality system regulation that apply to its operations

    • Equipment installation, maintenance, and equipment calibration

    • Installation and operation qualifications

    • Building adequacy

    • Personnel training

    • Environmental controls


Responsibilities of contract sterilizer cont
RESPONSIBILITIES OF LABORATORIESCONTRACT STERILIZER (cont.)

  • Quality system requirements:

    • Process controls

    • Documentation and record keeping

    • Acceptance of manufacturing materials

    • Procedures for handling process deviations

  • Any other requirement of the written agreement


Common problems found by fda
COMMON PROBLEMS FOUND BY FDA LABORATORIES

  • Manufacturer does not assume responsibility for sterilization performed by the contract sterilizer

  • Communication between the two parties of changes

  • Product is released following sterilization without approval of device manufacturer


Testing laboratory
TESTING LABORATORY LABORATORIES

  • Manufacturing Facility

  • Contract Laboratory

  • Contract Sterilizer


Lab attributes
LAB ATTRIBUTES LABORATORIES

  • Quality System

    • SOP

    • Calibrated equipment

    • Training

  • FDA Track Record

  • Experienced Personnel

  • Industry Reputation

  • Committed Client Services


Sterilization quality tests
STERILIZATION QUALITY TESTS LABORATORIES

  • Bioburden

  • Bioburden Recovery Validation

  • Sterility

  • Bacteriostasis and Fungistasis

  • Biological Indicators

  • Pyrogen or Bacterial Endotoxin

  • Inhibition and Enhancement


Sterilization quality tests cont
STERILIZATION QUALITY TESTS (cont.) LABORATORIES

  • Package Integrity

  • Chemical Residuals

  • Environmental Monitoring

  • Microbial Identification


Bioburden
BIOBURDEN LABORATORIES

  • Webster’s

    • bio (Greek) – life, living

    • burden – that which is carried, load

  • Medical Device

    • Population (number and types) of viable microorganisms on a product and/or a package


Bioburden test
BIOBURDEN TEST LABORATORIES

  • Three steps

    • Removal of microbes from a product

    • Culturing on a medium appropriate for growth

    • Enumeration

  • Bioburden Recovery Validation

    • Demonstrates the adequacy of the steps above


Bioburden methods
BIOBURDEN METHODS LABORATORIES

  • Pour plating

  • Spread plating

  • Membrane filtration

  • Automated microbiology systems


Sterility tests
STERILITY TESTS LABORATORIES

  • Product Sterility

    • Membrane filtration

    • Direct transfer

  • Biological Indicators (BI) Sterility

    • Testing the BI by placing it in microbiological growth medium


Sterility test validation
STERILITY TEST VALIDATION LABORATORIES

  • Bacteriostasis and Fungistasis (B & F)

    • Test using known organisms to demonstrate whether the combination of the product and sterilization method do or do not inhibit microbial growth


Sterility test usp vs aami iso
STERILITY TEST LABORATORIESUSP vs. AAMI/ISO

  • USP

    • Two microbiological media

      • SCDM and FTM

    • B&F (6 organisms)

  • AAMI/ISO

    • One microbiological medium

      • SCDM

    • B&F (3 organisms)


Biological indicator tests
BIOLOGICAL INDICATOR TESTS LABORATORIES

  • Three quality attributes may be measured:

    • Species identification

    • Population

    • Resistance

      • D-Value

      • Z-Value


Bacterial endotoxin test
BACTERIAL ENDOTOXIN TEST LABORATORIES

  • Endotoxin = Pyrogen

  • Bacterial Endotoxin Test = LAL Test

    • Gel clot method

    • Photometric techniques

      • Photochromogenic

      • Turbidimetric


Inhibition and enhancement test
INHIBITION AND ENHANCEMENT TEST LABORATORIES

  • Validation of the LAL test

  • 3 lots of product must be tested


Device packaging 21 cfr 820 130
DEVICE PACKAGING LABORATORIES21 CFR 820.130

“Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, handling, and distribution”


Device packaging 21 cfr 820 1301
DEVICE PACKAGING LABORATORIES21 CFR 820.130

  • Package integrity is required to maintain the microbial barrier and sterility of the product

  • Expiration dating

    • Required for IVD’s and certain other devices that may degrade over time

    • If label includes expiration, you must have data to back it up


Package integrity tests
PACKAGE INTEGRITY TESTS LABORATORIES

  • Dye Penetration

  • Microbial Challenge

  • Burst

  • Creep

  • Seal peal


Chemical residuals eo only
CHEMICAL RESIDUALS LABORATORIES(EO ONLY)

  • EO (ethylene oxide)

  • ECH (ethylene chlorohydrin)

  • EG (ethylene glycol)

    • No longer required


Environmental monitoring
ENVIRONMENTAL MONITORING LABORATORIES

  • Conducted in-house

  • Laboratory field technicians conduct sampling at manufacturing facility

  • Samples collected by sponsor’s personnel and incubated/counted at testing laboratory


Environmental monitoring tests
ENVIRONMENTAL MONITORING TESTS LABORATORIES

  • Non-viable particles

  • Viable particles

    • Bacteria

      • Soybean Casein Digest Medium (SCDM)

      • 30 – 35 °C

    • Yeast and Mold

      • Sbouraud Dextrose Agar (SDA)

      • 20 – 25 °C

    • Growth promotion required


Microbial identification
MICROBIAL IDENTIFICATION LABORATORIES

  • Morphological characterization

    • Colony description, Gram stain

  • Identification to genus and species level

    • Phenotypic

    • Genotypic


Microbial identification1
MICROBIAL IDENTIFICATION LABORATORIES

  • Biochemical Tests

    • Vitek

  • Fatty Acid Analysis

    • MIDI

  • Carbon Utilization

    • Biolog

  • Genetic Based Technology (preferred)

    • RiboPrinter


Microbial water tests
MICROBIAL WATER TESTS LABORATORIES

  • Total Heterotrophic Counts

  • Yeast and Mold Counts

  • Coliform Determinations

  • Thermophiles Counts

  • Anaerobes counts

  • Pseudomonas screening


Water tests
WATER TESTS LABORATORIES

  • Choice of Media

    • Plate Count Agar

    • Soybean Casein Digest Agar

    • R2A

    • Tryptone Glucose Extract

  • Choice of Incubation Temperature

    30-35°C, 20-25°C

  • Choice of Incubation Times

    2, 3, 5 or 7 days


Thank you

THANK YOU LABORATORIES

Q & A