PUTNAM, CT USA – (September 10, 2015) – Foster Corporation, a leader in custom polymers for medical devices, now offers custom colored medical polymers in quantities as low as 25 pounds (11 kgs) within a two week lead time to support market demand for rapid prototype development. These include formulations using pigments compliant with FDA requirements for use in applications that contact the human body for up to 30 days.
Medical devices often use custom colored components for branding, aesthetics, or functional purposes. Injection molding or extruding limited quantities of these components is common in early stage prototype development. Small quantities of custom colored polymers are desirable; yet, traditional minimum order quantities offered by many custom compounders range from 50 to several hundred pounds due to equipment and/or economic limitations. Foster’s 25 pound (11 kg) minimum order quantities is designed to meet the needs of manufactures in early stage development, and ultimately scalable for commercial manufacturing. Regulatory approval of devices that come in contact with the human body, such as catheters, may require custom colored polymers that use pigments certified by the Food and Drug Administration (FDA) under the Code of Federal Regulations (CFR), or FDA 21 CFR 73 Subpart D. These pigments
have been reviewed and approved by the FDA for contact with the human body. Foster’s 25 pound (11 kg) development quantities of custom colored polymers includes a range of options using pigments that meet this standard for human body contact.
“Foster’s regulatory and color matching departments collaborate in early stage pigment selection for custom colored medical polymers in order to facilitate FDA approvals for our customers,” said Alicia Bergeron, Regulatory and Safety Specialist for Foster Corporation. “This unique approach within the compounding industry is particularly beneficial for customers who need fast track regulatory approval and commercial launch.”