Cleanroom.net Product Exclusives : John Stover Of AdvantaPure Talks About Their New BioClosure Systems
Cleanroom.net Product Exclusives talks to Advantapure’s John Stover about their new High Purity Container Closures line of BioClosure™ Systems. The BioClosure Systems, are ideally suited for pharmaceutical, biotech, laboratory, and other clean applications. Practical for either repeated or single use, BioClosure Systems work with flexible container systems, laboratory bottles and apparatus, and sampling and storage receptacles of glass, plastics, or metal.
Cleanroom.net : Thanks John for talking to Cleanroom.net Product Exclusives. AdvantaPure have launched a complete line of container closures called the BioClosure System. Why did AdvantaPure develop this new product?
John : AdvantaPure was already manufacturing and molding pharmaceutical grade silicone tubing, tubing manifolds, tubing sets, and molded parts. BioClosures are used to seal various types of containers and vessels with various processing fluids or pharmaceutical products. These containers have to be filled in a sterilized condition. Silicone BioClosures withstands the various types of sterilization techniques used and is an excellent product to allow a high purity critical stream to fill and store fluids in a container without breaking sterility.
Cleanroom.net : What type of cleanroom is the product manufactured in?
John : A certified ISO class 7 clean room
Cleanroom.net : What certifications does the product have?
John : USP 85 (Endotoxin), 87 (Cytotoxicity), 88 (Class VI), 381 (Elastomeric Closures for Injection), 643 (Total Oraganic Carbon), 661 (Physicochemical tests for Plastics), USP Endotoxin, ISO 10993 (Biological Evaluation of Medical Devices), FDA 177.2600 Rubber Articles Intended for Repeated Use, and EP 3.1.9 (Tests on Silicone Elastomer for Closures and Tubing).
Cleanroom.net : What advantages does the BioClosure System offer over competitor’s products?
John : All BioClosure assemblies are made in ISO Class 7 Certified Clean Rooms. An ISO 9001;2008 quality certification ensures procedures that make repeatedly top quality closures. Rapid turn around times for orders minimizes large inventory needs for customers and ensures an un-inerrupted supply chain.
Cleanroom.net : What temperatures ranges can the BioClosure System operate in?
John : Withstands temperatures ranging between minus 100 deg F and 400 deg F
Cleanroom.net : Can buyers order customised versions of the BioClosure System?
John : Standard closure sizes and customized closure assemblies are available.
Cleanroom.net : Where can buyers get this product?
John : Call NewAge Industries/AdvantaPure Products to find a Local Distributor: 800-506-3924, regular phone number 215-526-2151 or visit the AdvantaPure Website: www.advantapure.com
John Stover is Director of New Business Development at NewAge Industries-AdvantaPure. Stover has been with the company for over 30 years and also served as Sales Manager and Director of Product Development. His extensive knowledge of plastics and their applications helped NewAge develop its high purity AdvantaPure product line. Stover can be reached at 215-526-2151 or email@example.com.
Our thanks to John for taking the time to talk to Cleanroom.net. And also a special thanks to Ann Phy of New Age Industries for all her help!