Celanese has a global network of product stewardship professionals with expertise to support our Customers’ use of Celanese’s medical and pharmaceutical grade materials in medical devices and pharmaceutical combination products.
We continuously monitor evolving applicable regulations such as FDA submission requirements, the European Medical Device Regulation, manufacturing, REACH/Substances of Very High Concern and Celanese products meet relevant regulatory standards.
As a member of the International Pharmaceutical Excipients Council (IPEC), an industry association for pharmaceutical excipient manufacturers, we participate in the association meetings to stay abreast of new regulatory guidelines and emerging global regulatory trends.
We are able to provide relevant certifications and documentation based on our customers’ individual needs and requirements during various stages of their development and approval processes. Such documentation can be mutually agreed with our customers in, and is subject to the terms of, contractual supply commitments with our customers.
Our medical regulatory support services can help optimize speed to market, provide consistent materials with proven safety that have been tested according to relevant compliance standards, and provide support during the lifecycle process for our customers’ products.
Regulatory support services that we may provide, depending on the materials and applications contemplated and subject to the terms of the applicable customer contract, include:
- Compliance statements / certification letters for certain relevant regulations
- Creation and maintenance of FDA Device Master Files or Drug Master Files, together with provision of and Letters of Authorization (LoA)
- Biocompatibility tests and certification letters
- Technical dossiers / documentation support per customer request
Below is a list of standard certifications that we may be able to provide for our medical and pharmaceutical grade materials, depending on the materials and applications contemplated and subject to the terms of the applicable customer contract:
- Biocompatibility ISO 10993 Parts 5, 6, 10, 11 / USP Class VI Certification;
- US and/or European Pharmacopoeia; Physicochemical USP 661.1
- FDA Compliance Statements / Food Contact Declarations for EU & US (EU 10/2011, US 21 CFR)
- Animal Origin Statement
- BSE/TSE Statement
- MDR Compliance Statement
- RoHS Compliance Document
- REACH Compliance Document
- Absence of Substances of Concern (e.g. Bisphenol A, Phthalates, Heavy Metals)
- California Proposition 65 Statement
- Residual Solvents Statement
- Allergens Statement
- CMR Statement (Carcinogenic, Mutagenic, and Reprotoxic Substances)
- Endocrine Disruptors Statement
Drug Delivery, Bioprocessing and Single Use Solutions, and Medical Device & Equipment
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