i want to know whether we detect endotoxin limit in Vial washing M/c, also i want to know how much percent of sodium chloride is used in PQ of vial washing m/c ?
Directive 21CFR part 211.92 states that containers used for parenteral drugs, shall be “clean”, “sterile” and “pyrogene free”. This can be accomplished by washing machines and sterilization/depyrogenation equipment. Although the FDA does not quantify the performance of the equipment, it does mandate equipment validation. Validating vial washers and sterilizing/depyrogenation equipment therefore is a subjective task.
The most effective way to remove contaminants from vials is through “scrubbing” with pure water. Most commonly used is Water For Injection (WFI), which is not only without particulates, but also without microorganisms and pyrogenes. This “scrubbing” is accomplished by high pressure water jets.
The effectiveness of this “scrubbing” is a function of the following factors:
1) The energy level of the WFI
2) The amount of WFI used per vial.
The higher the WFI temperature, the higher the energy level. High temperature WFI (80-90° C) is more effective in particulate removal than WFI at ambient temperature. High pressure water jets (5-6 bar) are more effective than low pressure water jets.
The amount of WFI is subject to the size of the vial.
Obviously, larger vials require more WFI than smaller vials.
In a vial washing machine, the amount of WFI is determined by:
- The cycle time (or speed setting) of the machine,
- The number of spraying stations
- The orifice of the spraying opening.
To test the ability to remove chemical contaminants, vials are spiked with a Sodium Chloride (NaCl) solution. After washing, no traces of NaCl should be detected.
Which guidelines it mentioned to use for vial spiking to check chemical cal removing capacity of machine ? I mean is there any reference for that.