The CS Analytical is the only FDA Regulated, cGMP contract laboratory that is solely dedicated to issues specific to container and package system qualification testing. The CS Analytical team Is committed to helping clients ensure all container and package system regulatory requirements are met. This All-Star team of package professionals have the knowledge and experience across a wide variety of package types and as we frequently relay to clients, “there are virtually no medical product package systems that we have not seen.”
This level of experience was further highlighted during our recent FDA inspection. Based upon the diligence the CSA Team brings to quality, the inspection was completed with no observations of note. More interesting for the CSA Team was the comprehensive review of the wide variety of package systems that were noted in the formal FDA Establishment Inspection Report (EIR).
PRODUCTS COVERED
The firm handles the following container closure systems and materials:
Primary Packaging Components and Systems – Type I, II, and III (Glass, Vials, Jars, Ampoules, Cartridges, Syringes (staked needle and luer lock).
Elastomers – Type 1 and Type 2 Lyo and Serum stoppers, Syringe / cartridge plungers, Septa, luer lock seals, and tip cap elastomers, Integrated liners / seals, as in cartridge crimps and threaded closures with integrated rubber seals or gaskets.
Plastic Vials, Cartridges, and Syringes (parenteral) – materials listed below (PE, PP, PET and Cyclic Olefins).
Cryovials – of varying types and materials.
Aluminum Crimp Seals – for both vials and cartridges.
Plastic Bottles – PE, PP, and PET.
Bottle Closures – CRC and non-CRC, with induction seal, with foam liner, with pressure sensitive seals, with no liner/seal.
Unit-dose containers – Stick packs (foil and plastic), Blisters / Blister Cards (thermoform and cold form /Alu).
Tubes (typically topical) – Aluminum tubes both coated or uncoated, Plastic tubes.
Flexible bag systems – Traditional IV bags and Cryogenic storage bags.
Miscellaneous / Unaddressed Packaging Components – Films and foils used to create any of the above listed components, Tins, Bulk storage / API poly bags and drums.
Novel primary packages or components under development – New materials using innovative drug delivery systems.
Secondary Packaging Components – Cartons, Labels, shrink wraps, Thermoformed trays, Tyvek lidding and pouches, Plastic overwraps, bags, and pouches, Foil bags / pouches.
Tertiary Components and Packouts – Shippers (Room temp, Refrigerated, Frozen, Ultracold, including dry ice shippers and liquid nitrogen shippers); Cryo pouches, cassettes, racks and vessels for cryogenically stored IV bags and vials; Palletized loads of the above inclusive of wooden and plastic pallets and associated, banding, stretch wrap, shipper labels, refrigerant packs.
Ancillary Packaging Components – Desiccants (unincorporated, in canisters, in woven pouches), compositions include CaCl, Silica Gel, Molecular Sieve, Activated Carbon, Calcium Oxide. Coils and compositions to include Cotton, Rayon, Polyester.
Miscellaneous Product Types – Empty capsule shells (Gelatin, HPMC); Associated packaging components (Dosing spoons, Oral dosing syringes, Metered dose pumps, Dose cups); Unique devices / packaging / combination product components (Autoinjector housings, Needle safety devices, Infusion / injection ports and systems, Spikes); Manufacturing / processing and intermediate systems (Bioprocessing bags, Bulk or API storage, In-process tubing, In-process gaskets or seals
The FDA EIR further noted upon review of multiple test reports and associated raw data files:
“The records reviewed included methods of material identification prior to compendia package integrity testing to establish the conditions of the test. The materials tested include Polymer Resins (homopolymers and copolymers of HDPE, LDPE, LLDPE, Blended Polyethylene, PET). It also includes the following family of compounds:
Polypropylenes, Cyclic Olefins, PVC, PVDC, EVA, EVOH, Aclar, PBT, PEN, Polyamide, Acrylic and Novel or innovative custom blends. Other groups of materials include Elastomeric materials. They are Bromobutyl rubbers, Silicone elastomers, Plasticized PVC, Fluoroelastomers, Butyl rubbers, Natural rubbers, Thermoplastic elastomers, Polyurethane and Isoprenes.
At CS Analytical, we take great pride in helping clients bring their products through FDA approval and to market for patient use. Our team of package system experts understand the regulatory process and challenges that clients face, and we are committed to using our knowledge and experience in helping clients work through the program in an easy and seamless manner. The fact that even the FDA takes notes of the wide range of experience that the CSA Teams brings to each testing project further solidifies that when it comes to qualification testing for your drug product package system, the CS Analytical team has the breadth of experience across any type of container and package system being used.