statpaktm
FDA Grade (ESD) Anti-static Drum Liners

STATPAK™ FP is an anti-static polythene film used for the safe loading and storage of fine powder chemicals and is ideal as liner for drums or FIBC’s. It is also used in the storage and transportation of powders and tablets. STATPAK™ FP (Drug Master File Number 10588) meets FDA Title 21 para. 178.3130.

Ideal for compliance with both FDA Title 21 and IEC 60079-32-1 (Para 9) for Electrostatic Powder risks in a single product solution.

STATPAK™ FP is available as bags, sacks, liners and hoods.

Product Background
These Pharma grade anti-static polythene liners have been in use for 20+ years and are used by Pharmaceutical companies and their API divisions for the bulk packaging of powders and tablets.

The product is made in house, using our film extrusion facilities and our dedicated Pharma conversion unit which contains the machinery to make the product into bags and the relevant test equipment. This provides quick response, traceability and control, which is vital for the multi-nationals we service. We ship the product all around the world.

These Liner bags are heavy duty, with strong seals using Pharma, Food Grade polymer and specialist anti-static additives in order to comply with various regulations. We respond quickly to product development teams, to help them meet Drug Registration Packaging Requirements filings. We are regularly audited.

Declarations are provided for various regulations, including Pharmacopeia, EEC Food Contact, FDA Food Contact and Certificates of Analysis which lists the electrical test results for each order.

Further manufacturing guidance has been provided in the products we make section.

Technical Data

STATPAK™ FP is a homogenous anti-static polythene film which is effective even at low relative humidity’s (less than 12%). Designed for the particular needs of the pharmaceutical industry, it meets FDA Title 21 CFR 177.1520 (Olefin Polymers) and FDA Title 21 para.178.3130 (anti-static agents). The special additives used do not affect the film clarity or quality and it is therefore most economical in use, as a standard film thickness can be selected.

Sizes
Liners are available to order in any size and gauge from imperial dimension 3” x 3” to 47” x 79” or metric dimension 75mm x 75mm to 1200mm x 2000mm (metric). We extrude material to the thickness you require and every product is made to your order. A common thickness is 400 Gauge (100mu) so the material is very thick to provide higher levels of protection. Minimum order quantities exist as film extrusion is a continuous process.

Quality Assurance

Quality Assurance is vital when supplying the pharmaceutical industry. We operate a rigorous in house Quality control programme and all STATPAK™ FP product batches are tested to FTS 101C method 4046 and ASTM D-257. Complete test certification documents accompany each shipment.

In terms of our manufacturing process, we operate under the ISO9001-2015 Standard, the BRC-IOP Packaging Standard and have a dedicated Pharma manual to cover other aspects of GMP.