- \n
- Key Certifications in the Pharmaceutical Industry<\/li>\n
- The Role of Documentation<\/li>\n
- How to Obtain Documentation<\/li>\n<\/ul>\n
Key Certifications for Fluid Handling Components in the Pharmaceutical Industry<\/h2>\n
1. United States Pharmacopeia (USP) Class VI<\/h3>\n
What is USP Class VI?<\/strong><\/h4>\n
The United States Pharmacopeia (USP) sets standards for the quality, purity, strength, and consistency of drugs and their components. USP Class VI, one of six classifications for plastics, is the most stringent. It certifies that plastic materials do not cause harmful reactions or long-term effects when they come into contact with living tissues. To earn this designation, materials must pass three biocompatibility tests: acute systemic toxicity, intracutaneous toxicity, and implantation. These tests ensure that materials used in pharmaceutical production are safe and do not leach harmful substances.<\/p>\n
Why Use It?<\/strong><\/h4>\n
USP Class VI is vital for drug manufacturing due to its strict biocompatibility and low-toxicity requirements. It ensures that no harmful chemicals leach into products, making it essential for fluid-contact surfaces like tubing, fittings, and single-use systems.<\/p>\n
![\"A](\"https:\/\/www.coleparmer.com\/blog\/wp-content\/uploads\/2025\/01\/using-lab-equipment.jpg\")
<\/p>\n\u00a0<\/p>\n
Products that meet USP Class VI standards:<\/em><\/p>\n
- \n
- Cole-Parmer\u00ae Sanitary Fittings, Straight Concentric Reducer, Polypropylene<\/a><\/li>\n
- Cole-Parmer\u00ae Sanitary Gaskets, PTFE<\/a><\/li>\n
- Cole-Parmer\u00ae Soft Thermoplastic Elastomer (TPE) Tubing<\/a><\/li>\n
- PharMed\u00ae BPT Biocompatible Peristaltic Pump Tubing<\/a><\/li>\n<\/ul>\n
2. U.S. Food and Drug Administration (FDA) CFR 21<\/h3>\n
What is FDA CFR 21?<\/strong><\/h4>\n
The U.S. Food and Drug Administration (FDA) plays a critical role in regulating pharmaceutical products, ensuring their safety, efficacy, and quality. The FDA\u2019s Code of Federal Regulations (CFR) Title 21 is the set of regulations that governs food and drug safety in the United States.<\/p>\n
Two common FDA certifications used in the pharmaceutical industry are:<\/h5>\n
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- FDA CFR 21 177.2600<\/em>: Governs rubber materials used in repeated contact with food, ensuring they don\u2019t introduce harmful substances.<\/li>\n
- FDA 21 CFR 177.1520<\/em>: Specifies the types of olefin polymers, including polyethylene and polypropylene, that are safe for use in food-contact applications.<\/li>\n<\/ul>\n
Why Use It?<\/strong><\/h4>\n
While originally designed for materials in contact with food, it is widely applied in the pharmaceutical industry. They ensure that elastomeric materials used in tubing, gaskets, and seals meet strict safety standards.<\/p>\n
![\"Gloved](\"https:\/\/www.coleparmer.com\/blog\/wp-content\/uploads\/2025\/01\/peristaltic-pump.jpg\")
<\/p>\nFDA compliant fluid handling components:<\/em><\/p>\n
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- Cole-Parmer\u00ae PFA Tubing<\/a><\/li>\n
- Cole-Parmer\u00ae Platinum-Cured Silicone Tubing, 61 Shore A<\/a><\/li>\n
- Black Viton\u00ae FDA-Compliant Tubing<\/a><\/li>\n
- Versilon\u2122 2001 Plasticizer-Free Chemical-Resistant Tubing<\/a><\/li>\n
- Cole-Parmer\u00ae Cleanroom Hose Barb Fittings, Straight Reducer, White Nylon<\/a><\/li>\n<\/ul>\n
3. European Pharmacopoeia (EP) 3.2.9<\/h3>\n
What is EP 3.2.9?<\/strong><\/h4>\n
For companies selling pharmaceuticals in Europe, adhering to the European Pharmacopoeia (EP) is essential. EP 3.2.9 is a standard that establishes guidelines for evaluating elastomeric closures. This guideline ensures component materials are free from harmful extractables and leachables, which could compromise product quality.<\/p>\n
Why use it?<\/strong><\/h4>\n
This guideline emphasizes the importance of comprehensive testing to mitigate risks associated with product contamination and ensure that pharmaceutical products maintain their quality throughout their shelf life. It is crucial for pharmaceutical manufacturers seeking to market their products in Europe, as it demonstrates adherence to high-quality standards and regulatory requirements.<\/p>\n
![\"Gloved](\"https:\/\/www.coleparmer.com\/blog\/wp-content\/uploads\/2025\/01\/tubing-app-1.jpg\")
Sani-Tech\u00ae STHT\u00ae-80 premium silicone tubing with high burst pressure capability.<\/p><\/div>\n
European Pharmacopoeia (EP) 3.2.9 compliant products:<\/em><\/p>\n
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- PharmaPure\u00ae Low Spallation Peristaltic Pump Tubing<\/a><\/li>\n
- C-Flex\u00ae 072 Thermoplastic Elastomer (TPE) Tubing<\/a><\/li>\n
- C-Flex\u00ae 374 Thermoplastic Elastomer (TPE) Tubing<\/a><\/li>\n<\/ul>\n
4. BSE\/TSE Free Certification<\/h3>\n
What is BSE and TSE?<\/strong><\/h4>\n
BSE (Bovine Spongiform Encephalopathy) and TSE (Transmissible Spongiform Encephalopathy) are neurodegenerative diseases that can be transmitted through animal-derived materials. It is critical to ensure that the products used throughout the development and manufacturing process do not use any animal-derived ingredients, and the product does not come into contact with animal products during storage or transportation.<\/p>\n
Why use it?<\/strong><\/h4>\n
BSE\/TSE Free Certification confirms that the materials used are free from any animal-derived substances that could carry the risk of BSE or TSE transmission. This certification is often required for materials used in single-use systems, bioprocessing, and sterile drug manufacturing to ensure the highest levels of safety and compliance. Although the prevalence of TSEs is low globally, it\u2019s important to take precautions to minimize their spread.
\n![\"Scientist](\"https:\/\/www.coleparmer.com\/blog\/wp-content\/uploads\/2025\/01\/Landscape-shot-of-Aseptiquik-in-action-hi-res-scaled-1.jpg\")
<\/p>\nProducts that are TSE and BSE free:<\/em><\/p>\n
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- Cole-Parmer\u00ae Sanitary Gaskets, Black EPDM<\/a><\/li>\n
- CPC\u00ae (Colder) Quick-Disconnect Fittings, Polysulfone<\/a><\/li>\n
- Tygon\u00ae SPT-3350 Platinum-Cured Silicone Tubing<\/a><\/li>\n
- Cole-Parmer\u00ae Cleanroom Female Luer to Hose Barb Fittings, Straight Adapter, Animal-Derivative-Free Polypropylene<\/a><\/li>\n<\/ul>\n
The Role of Documentation<\/h3>\n
While certifications ensure the quality and safety of fluid handling components, comprehensive documentation plays an equally vital role in regulatory compliance. Proper documentation helps establish traceability and accountability, which is crucial for audits, regulatory inspections, and maintaining quality standards.<\/p>\n
Types of Documentation:<\/h4>\n
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- Certificates of Conformance (CoC):<\/em> Documents that certify a product meets specified requirements, giving manufacturers confidence in the materials they use. A Certificate of Compliance typically includes several critical pieces of information to ensure full traceability and confidence in the product, including but not limited to the description, lot number, and shelf life where applicable.<\/li>\n
- Validation Packets:<\/em> Compressive packets that provide the necessary regulatory, performance, and safety standards for the testing and validation of component materials. Validation packets may include applicable compliance certificates, extractables and leachables, biocompatibility reports, or performance testing.<\/li>\n<\/ul>\n
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How to Obtain Documentation<\/h3>\n
![\"Cole-Parmer](\"https:\/\/www.coleparmer.com\/blog\/wp-content\/uploads\/2025\/01\/FluidHandlingCertificateOfCompliance_Social.jpg\")
Sample Compliance Document<\/p><\/div>\n
Working with reputable suppliers like Cole-Parmer, who are well-versed in documentation and regulatory requirements, can simplify the process of obtaining the necessary certifications and documentation.<\/p>\n
Cole-Parmer offers a convenient self-service certificate of compliance lookup function<\/a> that allows you to quickly access Certificates of Conformance (CoCs) for your purchased products. This feature requires no login\u2014simply enter the product lot number to retrieve the necessary documentation, streamlining the process of ensuring compliance.<\/p>\n
In addition to CoCs, Cole-Parmer offers material validation packets for applicable fluid handling components. Contact a Cole-Parmer representative to inquire about validation packets available for fluid handling products. https:\/\/www.coleparmer.com\/fluid-handling-solutions<\/a><\/p>\n
Warning:\u00a0These products are not approved or intended for, and should not be used for, medical, clinical, surgical or other patient-oriented applications.<\/em><\/p>\n
Related Articles\/Blog Posts<\/p>\n
https:\/\/www.coleparmer.com\/blog\/fda-compliance-temperature-monitoring-traceablelive\/<\/a><\/p>\n
https:\/\/www.coleparmer.com\/blog\/how-does-traceablelive-support-21-cfr-part-11-compliance\/<\/a><\/p>\n
https:\/\/www.coleparmer.com\/blog\/lab-accreditation\/<\/a><\/p>\n
- Validation Packets:<\/em> Compressive packets that provide the necessary regulatory, performance, and safety standards for the testing and validation of component materials. Validation packets may include applicable compliance certificates, extractables and leachables, biocompatibility reports, or performance testing.<\/li>\n<\/ul>\n
- CPC\u00ae (Colder) Quick-Disconnect Fittings, Polysulfone<\/a><\/li>\n
- C-Flex\u00ae 072 Thermoplastic Elastomer (TPE) Tubing<\/a><\/li>\n
- Cole-Parmer\u00ae Platinum-Cured Silicone Tubing, 61 Shore A<\/a><\/li>\n
- FDA 21 CFR 177.1520<\/em>: Specifies the types of olefin polymers, including polyethylene and polypropylene, that are safe for use in food-contact applications.<\/li>\n<\/ul>\n
- Cole-Parmer\u00ae Sanitary Gaskets, PTFE<\/a><\/li>\n
- Cole-Parmer\u00ae Sanitary Fittings, Straight Concentric Reducer, Polypropylene<\/a><\/li>\n