Aflex Hose Limited, a business division of Watson-Marlow Fluid Technology Group has emphasised the importance of using products that are within the rules and comply with FDA, USP, CE marking, 3-A and other specifying bodies.
Aimed specifically at the pharmaceutical and biotech industries, Aflex is proactively communicating with its customers following industry-wide concerns that some hose manufacturers have recently declared that their products no longer meet stringent FDA compliance requirement.
The issue relates specifically to the use of adhesive products in the hose manufacturing process. Several recent cases have come to light where competitors’ hoses made from PTFE, PFA and FEP are found to contain substances that are detrimental to both the rules and to end users’ products.
Group Product Compliance Manager at Watson-Marlow Fluid Technology Group, Sade Mokuolu Ph.D explains: “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.”
However, this risk can be eliminated through specification of Aflex products, explains Jeremy Hudson, Managing Director at Aflex Hose:
“Aflex products contain no adhesives, additives or bonding agents in their construction. 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 and as global leader in PTFE reinforced hoses, can offer superior quality products that will ensure your process is secure."
Partnering with your supplier is key to understanding whether their testing criteria adequately reflects the finished equipment in contact with the drug product and not the raw material tested to achieve compliance.
The Aflex product range of Bioflex Ultra, Corroflon, Corroline+, Pharmaline N and Pharmaline X meets and exceeds the criteria set down by these governing bodies. Manufactured to the highest standards, Aflex hoses meet stringent legislative guidelines.
Jeremy concludes: “It’s simple – ask your hose supplier is there adhesive in their product and if the answer is yes, its time to change.”
Please visit our website www.aflex-hose.com to view the full Aflex product range.