Therapeutic Goods Administration

Site

Laboratories Branch Microbiology – Microbiology

Accreditation No.

2432

Site No.

2664

Date of Accreditation

30 Jun 1989

Address

1 Tindal Lane
Canberra Airport, ACT 2609
Australia

tga.gov.au

Contact

Ms Erin Fitzgerald P: +61 (02) 62894107

Availability

Services conditionally available to external clients

Scope of Accreditation

Print scopes
Laboratories Branch Microbiology – Microbiology

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Analysis for microorganisms Bacterial isolates; Yeast isolates Identification MALDI-TOF in-house method MM02-78 (Bruker MBT RUO 11897 MSP Library Version 12)
Biological analysis of human and veterinary medicines including vaccines Medical devices Pyronema domesticum Qualitative selective enrichment

in-house method MM02-115
Medical devices; Medicinal preparations; Pharmaceuticals Aerobes - Total viable Membrane filter

in-house method MM02-115
Aerobes - Total viable Qualitative

in-house method MM02-115
Pseudomonads Qualitative

in-house method MM02-115
Test for sterility Direct inoculation

BP Appendix XVI A (in-house method MM02-49)
Staphylococcus aureus; Staphylococcus spp. Qualitative

in-house method MM02-115
Preservative efficacy Spread plate

BP Appendix XVI C, USP-NF 51, ISO 14730 (in-house method MM02-119)
Aerobes - Total viable Spread plate

in-house method MM02-115, 122
Anaerobes Qualitative

in-house method MM02-115
Escherichia coli​​​​ Qualitative

in-house method MM02-115
Medical devices; Pharmaceuticals Test for sterility Membrane filter

BP Appendix XVI A (in-house method MM02-49)
Medicinal preparations; Pharmaceuticals Candida albicans; Clostridium spp.​​​​; Escherichia coli​​​​; Pseudomonas aeruginosa; Staphylococcus aureus; Bile tolerant gram negative bacteria Qualitative

BP Appendix XVI B, EP, USP-NF 61, USP-NF 62 (in-house method MM02-115)
Lactobacillus spp. Spread plate

in-house method MM02-118
Aerobes; Yeasts and moulds Spread plate

BP Appendix XVI B, EP, USP-NF 61 and USP-NF 62 (in-house method MM02-115)
Aerobes; Yeasts and moulds Membrane filter

BP Appendix XVI B, EP, USP-NF 61, USP-NF 62 (in-house method MM02-115)
Salmonella spp. Qualitative

in-house method MM02-115
Osmophilic yeasts Qualitative

in-house method MM02-115
Biological analysis of other healthcare or pharmaceutical products and accessories Disinfectants Efficacy Antimicrobial suspension TGA Disinfectant Test (in-house method MM09-96, 105)

The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.

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