Microbiological analyses

Routine testing

Bactimm performs the following routine microbiological tests on large scale base in compliance with international guidances.

Test package

Bioburden testing
Total Aerobic Microbial Count
Total Yeasts and Moulds Count
Tests for specified micro-organisms
Sterility membrane filtration
Sterility direct inoculation
Efficacy of antimicrobial preservation
Tests for bacterial endotoxins (LAL)
Biological assay of antibiotics (plate)
Package integrity testing

ISO 11737-1
PhEur 2.6.12-A and PhEur 2.6.12-B
PhEur 2.6.12-A and PhEur 2.6.12-B
PhEur 2.6.12-A and PhEur 2.6.12-B
PhEur 2.6.1 and ISO 11737-2
PhEur 2.6.1 and ISO 11737-2
PhEur 5.2.3 and CTFA M3
PhEur 2.6.14
PhEur 2.7.2
EN-868

Validation

Validation services of Bactimm are performed as per GMP-GCLP and OECD-GLP guidelines. On request a study will be finalized with an OECD-GLP statement. A validation project comprises a study plan, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report. Validation studies are performed by dedicated staff with special training on study handling, in accordance with international guidelines (e.g. PhEur, USP, ICH, ISO, ASTM, CTFA).

Validation package

Validation of analytical methods as per PhEur/ USP

Suitability testing of total aerobic microbial count
Suitability testing of total yeast & mould count
Suitability testing of test for specified organisms
Validation of endotoxin tests (LAL)
Validation of sterility test membrane filtration
Validation of sterility test direct inoculation
Method suitability for biological assay of antibiotics

Process based validation

Microbial validation of sterilization with gamma irradiation (ISO 11137-2)
Validation of aseptic mediafills of health care products (ISO 13408)
Clean room classification & monitoring (GMP, ISO 14644/14698)
Microbial and physical testing of medical grade gases  (EN 737 and PhEur / GMP)
Microbial process capability scan

Disinfectants and antiseptics testing

  • Quantitative suspension test, evaluation of basic bactericidal activity (EN 1040)
  • Quantitative suspension, evaluation of basic yeasticidal & fungicidal activity (EN 1275)
  • Basic sporicidal activity testing (EN 14347)
  • Quantitative nonporous surface, evaluation of bactericidal and/or fungicidal activity (EN 13697)
  • Hygienic hand rub testing (EN 1500)
  • Surgical hand disinfectants testing (EN 12791)

Stability studies for Medical Device Industry

  • Design and development of accelerated aging studies (ASTM F-1980 and ICH Q1)
  • Sample storage for accelerated aging in climate cabinets (ASTM F-1980 and ICH Q1)
  • Sample storage for real time aging in climate cabinets (ASTM F-1980 and ICH Q1)
  • Full microbiological and physical testing (package integrity) service for aging studies

Stability studies are performed in temperature/humidity controlled and monitored cabinets in
compliance with ASTM guidelines. Standard chamber conditions include:

  • 25°C ± 2°C / 60% RH ± 5%
  • 40°C ± 2°C / 75% RH ± 5%

Environmental monitoring

Bactimm provides active support in development of Microbiological Monitoring Programs for clean room certification, operating theatres and medical gasses. Bactimm has active air samplers for and special samplers for testing compressed air and other compressed gasses.
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