Critical Certification Pty Ltd

Site

Critical Certification Pty Ltd

Accreditation No.

14520

Site No.

14563

Date of Accreditation

22 Jan 2001

Address

Unit 4, 18 Nells Road
West Gosford, NSW 2250
Australia

criticalsciences.com

Contact

Mr Paul Morgan P: +61 1300174531

Availability

Services available to external clients

Critical Certification Pty Ltd address map

Scope of Accreditation

Print scopes
Critical Certification Pty Ltd

ISO/IEC 17025 (2017)

Infrastructure and Asset Integrity

Service Product Determinant Technique Procedure Limitations
Evaluation of air control equipment Biological safety cabinets Air velocity and uniformity of air velocity Cold DOP AS 1807 clause 4.1, NSF ANSI 49 N5.2 for compliance with: AS 2252.1, AS 2252.2, NSF ANSI 49
Sound level Not applicable AS 1807 clause 4.7, NSF ANSI 49 N5.11 for compliance with: AS 2252.1, AS 2252.2, NSF ANSI 49
Air barrier containment Cold DOP AS 1807 clause 4.9 for compliance with: AS 2252.1, AS 2252.2
Work zone integrity Not applicable AS 1807 clause 4.3 for compliance with: AS 2252.1, AS 2252.2
Air barrier containment Potassium iodide (KI) discus AS 1807 clause 4.12
Particle count in work zone Automatic particle counter AS 1807.8 (2000), AS ISO 14644.1 for compliance with: AS 2252.1, AS 2252.2
Air flow; Air flow direction and visualization Not applicable NSF ANSI 49 N5.2, N5.3, N5.4 for compliance with: NSF ANSI 49
Air velocity and uniformity of air velocity; Gas tightness; Illuminance; Integrity of HEPA filter installations; Inward air velocity; Leakage; Sound level; Ultraviolet intensity; Work zone integrity Not applicable AS 1807.1;
AS 1807.5;
AS 1807.6;
AS 1807.15;
AS 1807.20;
AS 1807.21;
AS 1807.23;
AS 1807.25;
AS 2252.2 clauses 5.3.3, 5.3.4;
NSF/ANSI 49 Annex F methods F.2, F.3, F.4, F.5, F.9, F.11;

for the purpose of determining compliance with
AS 2252.1 clauses 5.2.1, 5.2.2, 5.3.1, 5.3.2;
AS 2252.2 clauses 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.6

Integrity of HEPA filter installations Cold DOP AS 1807 clause 4.4, NSF ANSI 49 N5.5 for compliance with: AS 2252.1, AS 2252.2, NSF ANSI 49
Illuminance Not applicable AS 1807 clause 4.5, NSF ANSI 49 N5.9 for compliance with: AS 2252.1, AS 2252.2, NSF ANSI 49
Inward air velocity Cold DOP AS 1807 clause 4.8, NSF ANSI 49 N5.3 for compliance with: AS 2252.1, AS 2252.2, NSF ANSI 49
Gas tightness Not applicable AS 1807 clause 4.11 for compliance with: AS 2252.1, AS 2252.2
Ultraviolet intensity Not applicable AS 1807 clause 4.10 for compliance with: AS 2252.1, AS 2252.2
Air barrier containment Potassium iodide (KI) discus

AS 1807.22; AS 1807.26

Recovery times Not applicable AS 1807.24 (2000), AS/NZS 14644.3 Annex B4 for compliance with: AS 2252.1, AS 2252.2
Clean rooms, pharmaceutical isolators and work stations Air pressure; Air velocity and uniformity of air velocity; Illuminance; Integrity of HEPA filter installations; Leakage; Recovery times; Sound level; Work zone integrity Not applicable AS 1807.1;
AS 1807.3;
AS 1807.5;
AS 1807.6;
AS 1807.7;
AS 1807.10;
AS 1807.15;
AS 1807.16;
AS 1807.24;
AS 2252.6 clauses 3.2.1, 3.2.2, 3.2.3, 3.3.2, 3.3.3;

for the purpose of determining compliance with
AS 4273 clauses 9.3, 9.4, 9.5;
AS ISO 14644.1 Annex A;
AS/NZS 14644.3 sections B4.2.2, B4.2.4, B6.2, B6.4, B12
Air pressure Not applicable AS/NZS 14644.3 Annex B1 for compliance with: AS 2252.6 (Clean Workstation), AS/NZS 14644.3 (Clean Room), AS 4273
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/NZS 14644.3 (Clean Room), AS 4273
Sound level Not applicable AS 1807.7 (2000), AS 1807 clause 4.7 for compliance with: AS/NZS 14644.3 (Clean Room), AS 4273
Air barrier containment Not applicable AS 1807.22 (2000), AS 1807 clause 4.9 for compliance with: AS 2252.6, AS/NZS 14644.3 (Clean Room), AS 4273
Inward air velocity Not applicable AS 1807.21 (2000), AS 1807 clause 4.8 for compliance with: AS 2252.6, AS ISO 14644.1 (Clean Room)
Sound level Not applicable AS 1807 clause 4.7 for compliance with: AS 2252.6 (Clean Workstation), AS/NZS 14644.3 (Clean Room)
Recovery times Not applicable  AS/NZS 14644.3 Annex B4 for compliance with: AS 2252.6, AS/NZS 14664.3
Illuminance Not applicable AS 1807 clause 4.5 for compliance with: AS 2252.6 (Clean Workstation), AS/NZS 14644.3 (Clean Room), AS 4273
Ultraviolet intensity Not applicable AS 1807 clause 4.10 for compliance with: AS 2252.6 (Clean Workstation), AS/NZS 14644.3 (Clean Room), AS 4273
Integrity of HEPA filter installations Cold DOP AS 1807 clause 4.4, AS/NZS 14644.3 Clause 4.2.7, Method B7 for compliance with: AS 2252.1, AS 2252.2, AS 2252.6 (Clean Workstation), AS/NZS 14644.3 (Clean Room), AS 4273
Work zone integrity Cold DOP AS 1807.5 (2000), AS 1807 clause 4.3 for compliance with: AS 2252.6 (Clean Workstation), AS/NZS 14644.3 (Clean Room), AS 4273
Particle count in work zone Automatic particle counter AS ISO 14644.1 Appendix A for compliance with: AS 2252.6 (Clean Workstation), AS ISO 14644.1 (Clean Room), AS 4273
Air velocity and uniformity of air velocity Cold DOP AS 1807 clause 4.1, AS ISO 14644.3 clause 4.2.2, 4.2.3, Methods B.2 for compliance with: AS 2252.6 (Clean Workstation), AS/NZS 14644.3 (Clean Room), AS 4273
Cytotoxic drug safety cabinets Inward air velocity Cold DOP AS 1807.21 (2000), AS 1807 clause 4.8 for compliance with: AS 2252.5

Integrity of HEPA filter installations Cold DOP AS 1807 clause 4.4 for compliance with: AS 2252.1, AS 2252.2, AS 2252.5

Air velocity and uniformity of air velocity Cold DOP AS 1807 clause 4.1 for compliance with: AS 2252.5

Sound level Not applicable AS 1807 clause 4.7 for compliance with: AS 2252.5

Ultraviolet intensity Not applicable AS 1807 clause 4.10 for compliance with: AS 2252.5

Sound level Not applicable AS 1807.16 (2000) for compliance with: AS 2252.5

Work zone integrity Not applicable AS 1807 clause 4.3 for compliance with: AS 2252.5

Gas tightness Not applicable AS 1807 clause 4.11 for compliance with: AS 2252.5

Particle count in work zone Automatic particle counter AS ISO 14644.1 for compliance with: AS 2252.5

Illuminance Not applicable AS 1807 clause 4.5 for compliance with: AS 2252.5

Air pressure Not applicable AS/NZS 14644.3 Annex B1 for compliance with AS 2252.5

Air barrier containment Cold DOP AS 1807.22 (2000), AS 1807 clause 4.9 for compliance with: AS 2252.5

Air barrier containment Potassium iodide (KI) discus AS 1807.12 for compliance with AS 2252.1, AS 2252.2
Fume cupboards and recirculating fume cabinets Extraction performance Face velocity; Smoke visualisation

AS/NZS 2243.8 Appendices A and B; AS/NZS 2243.9 Appendices A and B

Illuminance; Sound level Not applicable

AS 1807 clauses 4.5; AS 1807 clause 4.7

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 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
Sound level Not applicable AS 1807.20 (2000), AS 1807 clause 4.7 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

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