Materials of Construction of Single-use Systems

Although hundreds of industrial plastics and polymers are commercially available, types of materials used to manufacture biopharmaceutical single-use systems are limited due to their high-quality requirements. For examples, product contact materials used for single-use systems should be BSE/TSE risk free and meet USP class VI requirements. Also, it should complaint with CFR Title 21, part 211.65: “Equipment shall be constructed so that the 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”. The following table listed commonly used polymeric materials for single-use systems.

Abbreviations Chemical Name (Brand Name) Chemical Structure Examples of Applications
PE (HDPE, LDPE, ULPE, LLDPE) Polyethylene (Dowlex®, Engage®) -[CH2-CH2]- Film, bottles, clamps
PP Polypropylene (Moplen®, Profax®) Bottles, caps, clamps, filter cartridges and capsules, bag ports, fitting
PC Polycarbonate   Bottles, flasks, connectors  
PETG Polyester/Polyethylene terephthalate Bottles
PES Polyethersulfone   Filter media
PSU Polysulfone Connectors
EVA Ethylene vinyl acetate (Evatane®, Elvax®)   Bag film
EVOH Ethylene vinyl alcohol Bag film
PA Polyamide (PA) Bag Film
PTFE PTFE (Teflon®) Filters, stoppers, tubing
PVDF Polyvinyllidene fluoride (Kynar®)   Filters, stoppers, bag films, fittings, tubing
Si Silicone Tubing, gaskets, seals, O-rings
PS Polystyrene   Flasks, sampling tubes, bottles
PEEK Polyether ether ketone   Filling needles
EPDM Ethylene propylene diene monomer Seals, gaskets
PU Polyurethane Transfer belt
SEBS Polystyrene ethylene butylene styrene TPE Tubing
CA Cellulose Acetate Filter media
NC Nitrocellulose Filter media