CFR 21 Chemical Safety Testing in Pharmaceuticals
The Code of Federal Regulations (CFR) Title 21, Part 58, provides regulatory requirements for Good Laboratory Practice (GLP). Within this context, chemical safety testing ensures that pharmaceuticals are safe and comply with stringent regulations. This service focuses on assessing the flammability and other chemical properties of materials used in pharmaceutical products to ensure they meet legal and safety standards.
The testing process involves a series of rigorous procedures designed to identify potential hazards associated with chemicals used during drug development, manufacturing, and storage. Compliance with CFR 21 ensures that these materials are safe for use by the general public, healthcare professionals, and patients.
The scope of our services includes:
- Flammability testing
- Flash point determination
- Vapor pressure measurement
- Oxidizer detection
- Pure substance identification
- Mixture stability evaluation
- Hazardous waste classification
Our testing methodologies are aligned with international standards such as ISO 13428, ASTM E691, and EN 14507. This ensures that the results we provide meet global regulatory requirements.
The first step in our process is to receive a sample of the substance or mixture you wish to test. Once received, it undergoes rigorous preparation procedures including:
- Labeling with all necessary identifying information
- Segregation based on chemical properties and potential hazards
- Storage in appropriate environmental conditions
The sample is then subjected to a series of tests designed to evaluate its flammability characteristics. These tests include:
- Open cup flash point test (ASTM D56)
- Penetration calorimeter method (ASTM E2079)
- Vapor pressure determination using the ASTM D86 method
The results of these tests are analyzed to determine whether the substance poses a fire risk or potential hazard when exposed to heat, flame, or other sources. Compliance with CFR 21 ensures that pharmaceuticals do not contain any potentially harmful substances.
Once testing is complete, our team produces detailed reports that summarize all test results and provide recommendations for safe handling and use of the substance in question. These reports are designed to meet regulatory requirements and ensure compliance with international standards such as ISO 13428 and ASTM E691.
Our services are tailored to meet the specific needs of pharmaceutical manufacturers, healthcare providers, and research institutions. By providing accurate and reliable testing results, we help our clients ensure that their products meet regulatory requirements and are safe for use by the general public.
Industry Applications
| Application | Description |
|---|---|
| Pharmaceutical Manufacturing | Ensuring that raw materials and intermediate products are safe for use in manufacturing processes. |
| R&D Laboratories | Evaluating new compounds to determine their flammability and other chemical properties before they enter the production phase. |
| Quality Control Departments | Verifying that incoming materials meet specified safety standards. |
| Regulatory Compliance Officers | Ensuring that all testing and reporting comply with CFR 21 regulations. |
Why Choose This Test
The importance of chemical safety testing cannot be overstated. In the pharmaceutical industry, where products are ingested or applied to human skin, any potential hazard must be identified and mitigated early in the development process.
Our services provide peace of mind for those involved in pharmaceutical manufacturing, R&D, and quality control by offering accurate and reliable testing results. By identifying potential hazards early in the development process, our clients can avoid costly delays and ensure compliance with regulatory requirements.
The testing we perform is not only critical for ensuring product safety but also helps to protect public health. By providing detailed reports that summarize all test results, we enable our clients to make informed decisions about how best to handle potentially hazardous materials.
Our services are designed to meet the specific needs of those involved in pharmaceutical manufacturing and R&D. Whether you're a small startup or a large multinational corporation, our team is here to provide the support and expertise you need to ensure that your products meet regulatory requirements and are safe for use by the general public.
Quality and Reliability Assurance
We understand that quality and reliability are critical factors in pharmaceutical manufacturing. That's why our testing services are designed to provide accurate, reliable results every time. Our team of experts uses state-of-the-art equipment and follows strict protocols to ensure that all tests are conducted under controlled conditions.
Our commitment to quality is reflected in the certifications we hold from leading international standards bodies such as ISO 13428 and ASTM E691. These certifications demonstrate our unwavering dedication to providing high-quality, reliable testing results.
We also ensure that all of our clients receive detailed reports that summarize all test results and provide recommendations for safe handling and use of the substance in question. Our goal is to help you make informed decisions about how best to handle potentially hazardous materials.
By choosing our services, you can rest assured that your products will meet regulatory requirements and be safe for use by the general public. We are committed to providing the highest level of service and support to ensure your success in the pharmaceutical industry.
