Sterility Testing |
A claim of sterility must be supported by some type of testing, either that performed during the validation of the sterilization process, or testing performed on representative products after sterilization. AppTec can perform a variety of sterility tests under strict aseptic conditions, with a wide range of capabilities for handling large or complex products.
In this section |
| Bacteriostasis/Fungistasis Back to Top |
Bacteriostasis / fungistasis (B/F) testing is necessary to demonstrate that there are no substances produced by the test materials which would cause inhibition of bacterial or fungal growth in a sterility test (i.e., a false negative interpretation). Testing is performed by inoculating sterility test samples with low levels of selected organisms to ensure growth. B/F test parameters are based on USP, ISO, or AAMI requirements.
| 190105 | Sample device or material is tested for growth inhibition using the current USP organisms for Soybean-Casein Digest Medium (SCDM) and Fluid Thioglycollate Medium (FTM). (Additional organisms available upon request.) SAMPLE REQUIREMENTS
6 sterile product samples TURNAROUND TIME 10 days | | Bacteriostasis / Fungistasis – Two Media (USP) |
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| 190106 | Sample device or material is tested for growth inhibition using the current USP organisms for SCDM. This method is used when only SCDM (TSB) is used for sterility testing products. (Additional organisms available upon request.) SAMPLE REQUIREMENTS
3 sterile product samples TURNAROUND TIME 10 days | Bacteriostasis / Fungistasis –
One Medium |
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| Biological Indicators Back to Top |
Biological indicators (BIs) are carriers, such as a paper strip, that are inoculated with a specified level of a particular organism (typically Bacillus species). BIs are used to validate and / or monitor certain sterilization processes. Testing is performed according to either the BI manufacturer’s recommendations or USP, ISO, or AAMI requirements.
| 1201000 | Individual spore strips are transferred from their primary package to Tryptic Soy Broth (TSB) and incubated for 7 days for recovery of the indicator organism. SAMPLE REQUIREMENTS
Spore strips
(Client-provided positive control recommended.) SHIPPING
Overnight air. Protect from temperature extremes. TURNAROUND TIME 7 days, unless directed otherwise by client. | Biological Indicator
Direct Transfer |
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| 1203000 | Spore strips that have been placed within a product or its package are removed from the product or package and transferred to TSB for recovery of the indicator organism. SAMPLE REQUIREMENTS
Spore strips
(Client-provided positive control recommended.) SHIPPING
Overnight air. Protect from temperature extremes. TURNAROUND TIME 7 days, unless directed otherwise by client. | | "Inoculated" Biological Indicator |
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190300 - 3 Sample Composite
120200 - Single Sample | Before using a new lot of biological indicators (BIs) for sterilization load monitoring, the average strip population must be independently confirmed. SAMPLE REQUIREMENTS
Dependent on selected test. SHIPPING
Overnight air. Protect from temperature extremes. TURNAROUND TIME 5 days | Biological Indicator -
Total Viable Spore Count |
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| Inoculated Product Tests Back to Top |
Inoculated product consists of actual devices or materials that have been inoculated with a specified level of a liquid biological indicator (BI) suspension. Inoculated products are used to validate and / or monitor certain sterilization processes. Testing is performed by product immersion using either the BI manufacturer’s parameters or those found in USP, ISO or AAMI standards.
| 190200 | Devices are inoculated with an indicator organism appropriate to the sterilization system in use. SAMPLE REQUIREMENTS
No minimum. TURNAROUND TIME 7 days
Indicate required population and sterilization method. | | Product Inoculation |
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Inoculated Product Sterility
| Product that has been inoculated with a liquid spore solution (usually in a location determined as most difficult to sterilize) is tested in TSB and incubated for 7 days. SAMPLE REQUIREMENTS
Dependent on method and sterilizer volume.
(Client-provided positive control recommended.) TURNAROUND TIME 7 days, unless directed otherwise by client. | 1221010
Extra Small [≤ 100 ml of media]
1221000
Small [101 to 200 ml of media]
1221210
Medium [201 to 400 ml of media]
1221410
Large [401 to 600 ml of media]
1221610
Extra Large [601 to 1200 ml of media] |
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| 190501 | Liquid samples, including spore suspensions and inoculated liquids, are enumerated to confirm spore population. SAMPLE REQUIREMENTS
Dependent upon expected population. TURNAROUND TIME 5 days | | Liquid Sample Population Confirmation |
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| Liquid Sterility Tests Back to Top |
| 1222000 | Aliquot transfer designed for testing liquid product units ≤100 ml. SAMPLE REQUIREMENTS
Sample requirement is dependent upon lot size. TURNAROUND TIME 14 days, unless directed otherwise by client. | Liquid Sterility Test -
Direct Transfer |
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1223000 ≤ 200 ml
1225000 > 200 ml to ≤ 1000 ml | Designed to test liquid volumes ≥ 100 ml. Sterility testing is performed using sterile filtration. SAMPLE REQUIREMENTS
Sample requirement is dependent upon lot size. TURNAROUND TIME 14 days; 7 days if steam | Liquid Sterility Test -
Membrane Filtration |
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| Product Sterility Tests Back to Top |
Product sterility testing is typically performed in the validation of sterilization processes, and, in some cases, for monitoring sterilization cycles. Sterility tests involve either total immersion, membrane filtration, or a rinse method. The number of samples tested, the growth medium used, and the incubation conditions are based on the particular standard involved, either USP, AAMI/ISO, or FDA/CFR.
Product Test of Sterility
(ANSI/AAMI/ISO)
| Products are tested in Soybean-Casein Digest Medium at 30° ± 2°C for 14 days. SAMPLE REQUIREMENTS
Dependent on method used
(e.g., Method 1 requires 100 samples) TURNAROUND TIME 14 days, unless directed otherwise by client. | 1103010
Extra Small [≤ 100 ml of media]
1103000
Small [101 to 200 ml of media]
1104000
Medium [201 to 400 ml of media]
1105000
Large [401 to 600 ml of media]
1106000
Extra Large [601 to 1200 ml of media] |
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USP Product Sterility Test
| This testing is used to monitor sterilization loads using product. Products are tested in both Soybean-Casein Digest Medium and Thioglycollate Broth per USP guidelines. SAMPLE REQUIREMENTS
Up to 40 product samples. TURNAROUND TIME 14 days, unless directed otherwise by client. | 1220010
Extra Small [≤ 100 ml of media]
1220000
Small [101 to 200 ml of media]
1226000
Medium [201 to 400 ml of media]
1227000
Large [401 to 600 ml of media]
1228000
Extra Large [601 to 1200 ml of media] |
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AppTec offers additional sterility tests including: - Fluid Path Fill (in situ)
- Fluid Path Flush
- Pyronema
Contact your AppTec Account Manager regarding these tests and other available sterility tests. |
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