For absolute cleanroom (sterile
Room) A level area of equipment and personnel
Cleaning and disinfection
Sterile 70% (v / v) USP grade (USP)
Isopropyl alcohol solution
The basic anion surfactant
Class 100 (ISO 5) clean room
Double bagging
Bottled or bagged
0.22 microns filtered
Gamma-ray
Strict process:
Economically and efficiently dilution:
By soaking, washing, or ultrasonic shock bowl
Pipettes, test sample cup flashpoint
Product mixers, filters, HPLC vials
Label removed, silicone and hydrocarbons
Food plant and machinery
SAL 10-6 to ensure the level of sterility.
By USP14 day sterility testing.
Accompanied by a copy of the document accompanying the batch-specific.
WFIQ identified by USP 24 method <85>
In the detection of bacterial endotoxin content of less than 0.25 EU /mL.
Compliance with FDA 21 CFR section 10.96 specification.