All packaging films and structures meet FDA Codes of Federal Regulation 21 CFR 177.125 and others, depending on film and structure.
All Cleanroom films are acquired from qualified sources using prequalified, pre-tested resins with yearly ‘no change agreements’ extending to our customer base.
All Precision Clean packaging films are periodically tested for metal ion concentration per EPA 9056 / 6010B and outgassing of hydrocarbons per EPA 8260.
The Cleanroom air meets ISO Class 4 and Cleanroom Pouch Rooms, ISO Class 7; as defined by Cleanroom ISO Standard 14644-1. (Comparison Chart ISO to obsolete Fed 209E available.)
There are 36 zones among the two cleanrooms checked weekly per ISO 14644-2 for airborne particulate performance and each is recertified twice yearly by Lab Safety Corp.
Contamination Control is managed per Mil-HDBK-407.
There are over 100 HEPA filters maintaining the air quality in Cleanroom I and 37 in the smaller Cleanroom II.
Cleanroom Housekeeping is maintained in accordance with IEST RP-CC018.4.
All packaging manufactured by Fisher Container Corp. is tested per established ASTM industry methods as shown on the film product Marketing data sheets.
All Precision Clean Cleanroom packaging orders are tested per Liquid Laser Particle count; which, depending on product style are certified to meet various levels of Kennedy Space Center industry specification KSC-C-123J; JPG 532.1 with correlations to IESTSTD-CC-1246D revisions of the mil spec.
General physical test capabilities include tensile properties; seal strength; seal creep; burst; leak; COF; autoclave sterilization/validation; IR analysis and others.
All 8 Key Processes of the QMS are certified to the latest edition of the ISO 9001:2008 standard with four outside audits per year.