Extractable Profile Testing of Elastomers
The process of extractable profile testing is essential in pharmaceutical manufacturing to ensure that elastomers used in drug delivery systems do not leach potentially harmful substances into the medicinal products. This service ensures compliance with regulatory standards and enhances product safety by identifying any materials that could interfere with the efficacy or stability of medications.
Elastomers are a critical component in various pharmaceutical applications, including rubber stoppers for vials, tubing, and seals. The extraction process involves exposing these elastomeric components to simulated environmental conditions to mimic real-world scenarios such as storage temperatures, humidity levels, and exposure to solvents used during production processes.
The testing methodology follows international standards such as USP General Chapter <661> and ISO 3606-2. These guidelines provide specific protocols for the extraction of potential impurities from rubber materials that come into contact with pharmaceutical products.
Our laboratory uses advanced analytical techniques including High Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), and Fourier Transform Infrared Spectroscopy (FTIR) to detect trace amounts of extractables. This allows us to provide detailed profiles that help manufacturers assess the safety profile of their products.
Compliance with regulatory requirements is paramount in pharmaceutical manufacturing, and our services ensure that your elastomers meet these stringent standards. By providing thorough analysis, we support your efforts towards achieving product quality assurance and reliability.
Quality and Reliability Assurance
The quality and reliability of pharmaceutical products are directly influenced by the materials used in their manufacturing processes. Ensuring that these materials meet stringent specifications is crucial to maintaining the integrity of the final product. Our laboratory offers a comprehensive suite of services designed to support your compliance efforts.
- Comprehensive extraction testing
- Identification and quantification of extractables
- Evaluation against regulatory guidelines
- Development of custom protocols for specific applications
We work closely with our clients to understand their unique needs and develop tailored solutions that meet both internal and external requirements. Our expertise in this area allows us to offer valuable insights into potential risks associated with elastomers, helping you make informed decisions about material selection.
International Acceptance and Recognition
- USP <661>
- Pharmacopoeia of the People's Republic of China (ChP)
- European Pharmacopoeia (Ph. Eur.)
- International Conference on Harmonisation (ICH) Q7A
Our laboratory adheres to these widely recognized standards, ensuring that our results are accepted globally within the pharmaceutical industry.
Use Cases and Application Examples
| Application | Description | Purpose |
|---|---|---|
| Rubber Vials for Parenteral Medications | Vials made from elastomers that come into direct contact with injectable drugs. | To ensure no leachables interfere with the medication's effectiveness. |
| Plastic Tubing in Pharmaceutical Filling Lines | Tubing used for transferring liquids during manufacturing processes. | To prevent contamination and maintain product purity. |
| Seals and Gaskets in Drug Delivery Systems | Gaskets that ensure airtight seals around containers holding liquid medications. | To avoid leakage of active ingredients. |
