Aflex Hose — a business division of Watson-Marlow Fluid Technology Group — has emphasized the importance of using products that are within the rules and comply with regulatory bodies’ specifications.
Guidance
This guidance, specifically aimed at the pharma and biotech industries, follows industry-wide concerns that some hose manufacturers are no longer using products that no longer meet stringent FDA compliance requirements.
The issue relates to the use of adhesives used in the hose manufacturing process in particular, with several recent cases involving hoses made from PTFE, PFA and FEP that contained substances deemed to be detrimental to both the rules and to the end users’ products.
Group product compliance manager at Watson-Marlow Fluid Technology Group, Sade Mokuolu PhD explained: “Certain smooth bore hoses on the market use highly volatile carcinogenic adhesives to bond the inner liner to the supporting outer structure of the hose. This substance can come into contact with the drug product flowing through the hose, causing contamination and possibly catastrophic repercussions for users.
“As stated in FDA code of federal regulations, current good manufacturing practice guide, 21 CFR 211.65:
(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
“The theory is that this adhesive, which contains highly reactive and non-FDA approved chemicals, will never come into contact with the fluid media passing through the hose. However, it is known that electro-static discharges can occur which creates tiny pinholes in the fluoroplastic hose lining. Although these pinholes do not show as leaks, they do allow the adhesive to be leached to contaminate the process fluid.”
Partnership with the supplier is key to understanding whether testing criteria adequately reflects the finished equipment in contact with the drug product and not the raw material tested to achieve compliance. As Jeremey Hudson, managing director at Aflex Hose stated: “It’s simple — ask your hose supplier is there adhesive in their product and if the answer is yes, it’s time to change.”
“Aflex products contain no adhesives, additives or bonding agents in their construction,” he continued. “Very simply, our message is that no adhesive, means zero risk to users, the end product or the end customer. It is essential that anyone concerned by recently circulated stories from certain manufacturers checks that their current supplier can offer this level of assurance. We are here to help…”