Opira Pty Ltd

Site

Opira Laboratory

Accreditation No.

15597

Site No.

16622

Date of Accreditation

07 Feb 2008

Address

32 Dividend Street
Mansfield, QLD 4122
Australia

opira.com.au

Contact

Mr Dale Howard 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
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

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.

Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.