Pilot scale film extruder.
Typical production scale film extruder: Source - Internet
Storage of pharmaceutical compounds is a function of the storage process and not a specific containment driven requirement per se. This is the case whether you are processing in a contained fashion or performing non-contained processing into open kegs with simple drum liners.
The following is the priority in order that we use when looking at the development of the ArmorFlex family of films:
* Meet the surface resistivity and charge decay requirements since used in an explosive environment and given the static charge build up seen when transferring powders
* Have no constituents of animal origin
* Be food contact acceptable
* Meet applicable FDA, USP, EP and EMEA specifications
* Be compatible with the API being stored.
Selecting a supplier that understands these requirements, has the experience to work with the FDA to submit and maintain the Drug Master Files that will be needed for your Drug Application filings, work with your in-house regulatory compliance and materials packaging experts, and be aware of changing global regulations is a valuable asset to take advantage of. Our materials development team is just another example of where ILC Dover is an important extension of your team. We fully understand, apply, control, and certify our products to the applicable sections set forth under the various guidelines that have been established for materials of contact.
Included in this are the existing as well as new regulations covered under the European Medicines Agency (EMEA) Guidelines and EU directives such as 2002/72/EC and it's amendments for example. We routinely interface with many world wide experts at International Pharmaceutical Manufacturers.
ArmorFlex 114 is just one instance where ILC leads the industry in this arena.This has lead to the development of this non-migratory, static dissipative film as described in our ArmorFlex 114 (PDF)