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Quality
- Materials
- The Cleanroom
- Packaging Testing
- Systems
- All packaging films and structures meet FDA Codes of Federal Regulation 21 CFR 177.125 and others, depending on film and structure.
- All Precision Clean packaging films are made of "virgin" material with no regrind or "slip" allowed.
- 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 costly 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 cerified to meet various Levels of the Kennedy Space Center industry specification KSC-C-123J; JPG 5322.1 with correlations to IESTSTD-CC-1246D, revision 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
- Order Entry.
- Axapta Inventory / Production Management Systems - through raw to ship tracking (bar coding)