1. Purpose of Sterility Testing
The purpose of this Standard Operating Procedure (SOP) for Sterility Testing is to establish a systematic process for conducting sterility testing within [Company Name]. This SOP ensures that sterility tests are performed accurately, consistently, and in compliance with regulatory requirements.
2. Scope of Sterility Testing
This SOP for Sterility Testing applies to all personnel responsible for conducting sterility testing within [Company Name]. It encompasses the procedures for sample preparation, test method execution, and result interpretation.
3. Definitions
3.1 Sterility Testing:
A microbiological test performed to determine the absence of viable microorganisms in a sample or product.
4. Safety Precautions and Personal Protective Equipment (PPE)
4.1. PPE Requirements
4.1.1 Personnel conducting sterility testing must wear appropriate PPE, including lab coats, gloves, safety goggles, and face masks.
4.1.2 PPE should be properly inspected for damage or wear before use.
4.2. Chemical Safety
4.2.1 Handle testing reagents and chemicals following manufacturer instructions and in accordance with Material Safety Data Sheets (MSDS).
4.2.2 Store chemicals in designated areas away from samples and equipment.
5. Sample Preparation
5.1. Sample Collection
5.1.1 Collect samples using aseptic techniques to prevent contamination.
5.1.2 Document the sample collection details, including date, time, location, and sample identification.
5.2. Sample Handling
5.2.1 Transport samples to the sterility testing area using suitable containers to maintain sample integrity.
5.2.2 Avoid any unnecessary exposure to external environments during sample handling.
6. Sterility Testing Procedure
6.1. Incubation
6.1.1 Inoculate samples into appropriate sterile growth media.
6.1.2 Incubate samples at the specified temperature and time as per test method requirements.
6.2. Evaluation
6.2.1 After the incubation period, visually inspect the growth media for microbial growth.
6.2.2 Perform additional tests if indicated by the presence of growth.
7. Result Interpretation
7.1. Positive Result
7.1.1 If microbial growth is observed, consider the sample as contaminated.
7.1.2 Document the result, isolate the contaminated sample, and initiate an investigation.
7.2. Negative Result
7.2.1 If no microbial growth is observed, consider the sample as sterile.
7.2.2 Document the result and record it in the test report.
8. Documentation and Recordkeeping
8.1. Test Records
8.1.1 Maintain detailed records of each sterility test, including sample information, test conditions, and results.
8.1.2 Ensure that all records are signed, dated, and readily accessible for review.
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