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Sterility testing

ECACC offers a sterility testing service; cell lines and cell culture media can be submitted for testing to determine if microbial contamination is present. This is carried out using classical culture techniques, which are compared to positive and negative controls.

ECACC isolates bacteria and fungi using two United States Pharmacopeia (USP)/European Pharmacopeia (EP) recommended media:

  • Fluid thioglycollate medium (FTM) for the detection of aerobic and anaerobic bacteria.

  • Tryptose soya broth (TSB) for the detection of aerobes, facultative anaerobes and fungi.

Bacteria and fungi testing by culture to FDA Code of Federal Regulations. Title 21 (610.12)

Price

£118.45 (per sample)

Please note that prior approval of QC testing GMO2 samples is required. Please contact culturecollections.quality@ukhsa.gov.uk for more information.

Any biological material can be Mycoplasma and/or sterility tested if it is cell culture compatible. Please complete the Sample Submission form (see below) and the Biohazard Risk Assessment - Cell Lines and send both forms to us prior to arranging shipment of samples. Once the forms have been received, reviewed and accepted by ECACC, you will be issued with a reference number that will need to be quoted in all future correspondence (and on your samples). A Purchase Order number is also required before any sample can be processed.

If sending growing cultures:

  • growing cultures should have been passaged twice in the absence of antibiotics. They should have been growing for three days since the last medium change. ECACC need to be notified of the time of the last medium change so that, if necessary, the minimum growth time in the absence of antibiotics can be completed at ECACC

  • growing cultures should be sent in flasks topped up with medium. The flask cap should be of the non-vented variety and wrapped e.g. in parafilm, to prevent leakage

If sending frozen cultures:

  • a handling fee will be charged to cover costs of establishing the cell lines in culture

  • details of the cell line growth media and culture conditions must be supplied

Flasks and ampoules should be adequately packed and transported according to UN 602 regulations. Approved UN 602 packaging may be obtained from several suppliers, the details of which are available from any Royal Mail Sales Centre. If you use a courier service to ship your samples, please contact the company involved for advice on their own approved packaging.

Parcels should be addressed to: QC Testing Department, Culture Collections, UK Health Security Agency, Porton Down, Salisbury, SP4 0JG, UK

Testing is initiated on Tuesdays and Fridays and takes two weeks for a definitive result. Notification of dispatch of samples to ECACC is very much appreciated.

Name of Test

Catalogue Number

Sensitivity

Time Taken

Species Range

Meets FDA points to consider in characterisation of cell lines used to produce biologicals (1993)

Mycoplasma detection by PCR

(SOP: ECC73)

ECSR33

Low/Medium

1 day

Majority

No

Mycoplasma detection by Indirect Hoechst Stain

(SOP: ECC137)

ECSR60

Medium

3 days

All

Yes

Mycoplasma detection by Culture Isolation

(SOP: ECC146)

ECSR61

High

4 weeks

Majority

Yes

All three Mycoplasma detection methods:

(SOPs see above)

PCR, Indirect Hoechst Stain and Culture Isolation

ECSR39

High

4 weeks

All

See above for each test

Sample preparation from frozen amp

(not UKAS accredited)

ECSR30

N/A

N/A

N/A

N/A

Your details
Purchase order number
Please ensure this name matches the name on the biohazard form and the sample









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