Download Sample Submission Form for Mycoplasma and Sterility Testing Once

Sample Submission Form for Mycoplasma and Sterility Testing
Once completed please email to [email protected] with a completed Biohazard Risk
Assessment Form (available from www.phe-culturecollections.org.uk) and a copy of your purchase order.
Name
Organisation Name
Email Address
Telephone Number
Postal Address
Purchase Order (PO) Number
Please email a copy of your purchase order
Cell Line Name
Is the cell line growing and passaged twice in the absence of antibiotics? Yes
No
If the answer to the question above is No please provide details (including media details if applicable).
Note: ECACC may charge a handling fee for passaging cells prior to testing.
Mycoplasma Tests Required:
Mycoplasma Testing Method Characteristics
Name of Test
Mycoplasma Detection by PCR
Mycoplasma Detection by
Indirect Hoechst Stain
Mycoplasma Detection by
Culture Isolation
All three Mycoplasma
Detection methods:
Mycoplasma Detection by PCR,
Indirect Hoechst Stain and
Culture Isolation
Mycoplasma Detection by
Culture Isolation to FDA
protocol
Catalogue
Number
Select Tests
Required
(check box if
required)
Sensitivity
Time Taken Species
Meets FDA points to
Range consider in characterisation
of cell lines used to
produce biologicals (1993)
ECSR33
Low/Medium
1 day
Majority
No
ECSR60
Medium
2-3 days
All
Yes
ECSR32
High
3-4 weeks
Majority
No
ECSR39
High
3-4 weeks
All
See above for each test
ECSR35
High
3-4 weeks
Majority
Yes
Sterility Tests Required:
Sterility Testing by Microbiological Culture (BF01 ECSR04) Yes
No
Bacteria and fungi testing by culture to FDA Code of Federal regulations (21CFR) (BF03 ECSR05)
Yes
No
ECCW192.01-15 Authorised by: Dawn Osborne
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Effective Date 16.01.2015
Culture Collections, Public Health England, Porton Down, Salisbury, SP4 0JG, UK
T: +44 (0) 1980 612512 F: +44 (0) 1980 611315 E: [email protected] W: www.phe-culturecollections.org.uk