National Association of Testing Authorities, Australia
Scope of Accreditation
Opira Pty Ltd
Site
Opira Laboratory
Accreditation No.
15597
Site No.
16622
Date of Accreditation
07 Feb 2008
Contact
Mr Curtis Bettell P: +61 (07) 34145514
Availability
Services available to external clients
Scope of Accreditation
Opira Laboratory
ISO/IEC 17025 (2017)
Infrastructure and Asset Integrity
Service | Product | Determinant | Technique | Procedure | Limitations |
---|---|---|---|---|---|
Evaluation of air control equipment | Biological safety cabinets; Cytotoxic drug safety cabinets | Work zone integrity | Not applicable | AS 1807.5 (2000), AS 1807 clause 4.3 | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets) |
Gas tightness | Not applicable | AS 1807.25 (2004), AS 1807 clause 4.11 | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets) | ||
Illuminance | Not applicable | AS 1807.15 (2000), AS 1807 clause 4.5, NSF ANSI 49 N5.9 | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets), NSF ANSI 49 | ||
Air barrier containment | Cold DOP | AS 1807.22 (2000), AS 1807 clause 4.9 | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets) | ||
Integrity of HEPA filter installations | Cold DOP | AS 1807.6 (2000), AS 1807.7, AS 1807 clause 4.4, NSF ANSI 49 N5.5 | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets), AS 4260 clause 5.2, NSF ANSI 49 | ||
Inward air velocity | Cold DOP | AS 1807.21 (2000), AS 1807 clause 4.8, NSF ANSI 49 N5.3 | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets), NSF ANSI 49 | ||
Ultraviolet intensity | Not applicable | AS 1807.23 (2000), AS 1807 clause 4.10 | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets) | ||
Sound level | Not applicable | AS 1807.20 (2000), AS 1807 clause 4.7, NSF ANSI 49 N5.11 | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets), NSF ANSI 49 | ||
Air flow | Not applicable | NSF ANSI 49 N5.4 | for compliance with: NSF ANSI 49 | ||
Particle count in work zone | Automatic particle counter | AS 1807.8 (2000), AS ISO 14644.1 Appendix A | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets) | ||
Air velocity and uniformity of air velocity | Cold DOP | AS 1807.1 (2000), AS 1807 clause 4.1, NSF ANSI 49 N5.2 | for compliance with: AS 2252.2 (Biological safety cabinets), AS 2252.5 (Cytotoxic safety cabinets), NSF ANSI 49 | ||
Clean rooms | Air velocity and uniformity of air velocity | Cold DOP | AS 1807.3 (2000), AS ISO 14644.3 clause 4.2.2, 4.2.3, Methods B.2, B.3 | for compliance with: AS ISO 14644.1, AS ISO 14644.3 | |
Clean rooms, pharmaceutical isolators and work stations | Integrity of HEPA filter installations | Cold DOP | AS 1807.6 (2000), AS 1807.7, AS 1807 clause 4.4 AS/NZS 14644.3 Clause 4.2.7, Method B7 | for compliance with: AS 2252.6 (Clean Workstation), AS 4260 clause 5.2, AS 4273 clause 9.3 (Pharmaceutical isolators), AS ISO 14644.1 (Clean Room), AS ISO 14644.3 (Clean Room) | |
Work zone integrity | Cold DOP | AS 1807.5 (2000), AS 1807 clause 4.3 | for compliance with: AS 2252.6 (Clean Workstation), AS ISO 14644.1 (Clean Room), AS ISO 14644.3 (Clean Room) | ||
Air pressure | Not applicable | AS 1807.10 (2000), AS ISO 14644.3 clause 4.2.1, Method B.1 | for compliance with: AS 2252.6 (Clean Workstation), AS 4273 clause 9.5 (Pharmaceutical isolators), AS ISO 14644.1 (Clean Room), AS ISO 14644.3 (Clean Room) | ||
Illuminance | Not applicable | AS 1807.15 (2000), AS 1807 clause 4.5 | for compliance with: AS 2252.6 (Clean Workstation), AS ISO 14644.1 (Clean Room), AS ISO 14644.3 (Clean Room) | ||
Particle count in work zone | Automatic particle counter | AS 1807.8 (2000), AS ISO 14644.1 Appendix A | for compliance with: AS 2252.6 (Clean Workstation), AS ISO 14644.1 (Clean Room), AS ISO 14644.3 (Clean Room) | ||
Ultraviolet intensity | Not applicable | AS 1807.23 (2000), AS 1807 clause 4.10 | for compliance with: AS 2252.6 (Clean Workstation), AS ISO 14644.1 (Clean Room), AS ISO 14644.3 (Clean Room) | ||
Air velocity and uniformity of air velocity | Cold DOP | AS 1807.1 (2000), AS 1807 clause 4.1 | for compliance with: AS 2252.6 (Clean Workstation), AS 4273 clause 9.4 (Pharmaceutical isolators) | ||
Fume cupboards and recirculating fume cabinets | Extraction performance | Face velocity | AS/NZS 2243.8 Appendix B, AS/NZS 2243.9 Appendix B | for compliance with: AS/NZS 2243.8, AS/NZS 2243.9 | |
Illuminance | Not applicable | AS 1807.15 (2000), AS 1807 clause 4.5 | for compliance with: AS/NZS 2243.8, AS/NZS 2243.9 | ||
Extraction performance | Smoke visualisation | AS/NZS 2243.8 Appendix A, AS/NZS 2243.9 Appendix A | for compliance with: AS/NZS 2243.8, AS/NZS 2243.9 | ||
Sound level | Not applicable | AS 1807.20 (2000), AS 1807 clause 4.7 | for compliance with: AS/NZS 2243.8, AS/NZS 2243.9 |
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Accreditation No.
15597
Site No.
16622
Print date
03 Nov 2024
END OF SCOPE