Sterility Testing – Direct Inoculation (Non-GLP)

[vc_row][vc_column width=”1/1″][vc_empty_space height=”20px”][vc_column_text]This assay is performed as described in the United States Pharmacopeia National Formulary USP30/NF25. One-half of test article is placed in Fluid Thioglycolate Medium (FTM) and incubated at 32.5 C + 2.5 C. The other half of the test article is placed in Soybean Casein Digest Medium (SCDM) and incubated at 22.5 C + 2.5 C. Both media vials are incubated for 14 days and examined visually for turbidity on days 3, 7 and 14, the last day of the test period. At the same time, one uninoculated container of each medium is designated as a negative control and examined on days 3, 7 and 14.

A final reports that details the procedures performed is issued and reviewed by the quality assurance unit.

The sponsor will NOT be required to review and approve a protocol prior to study initiation. Please fill out the sample submission form below in either Word or PDF format and send along with the samples.[/vc_column_text][vc_empty_space height=”20px”][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][/vc_column][vc_column width=”1/2″][vc_row_inner][vc_column_inner width=”1/2″][vc_column_text]

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Sample Submission Form

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Sample Submission Form

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