By product typeBy application
Validation Items Validation Service
2015-01-14
Ophthalmic preparations ranging from contact lens cleaning and storing solutions to washing solutions in eye surgery and eye treatment products must meet the rigid regulatory requirements and product specifications. The major component of most ophthalmic solutions is water. Furthermore, there maybe salts such as NaCl, preventatives, vaseline for the production of ointments and gel polymer used for lubricants. Heat-sensitive ophthalmic solutions can be sterilized by sterilizing filtration or by adding sterilized components into pre-sterilized bulk solutions.
Separation Goals
●Prefiltration
Reduce particles and bioburden prior to sterilizing filtration
● Sterilizing filtration
Keep reliable retention of microorganisms for a long time
Application Requirements
● Filters must provide consistent high flow rates and be robust to satisfy mass manufacturing processes.
● Sterilizing filters must keep reliable retention of microorganisms for a long time.
● Filters must have no adsorption or binding of preservatives in product manufacturing.
Recommendation
Filtration Step | Recommendation |
Prefiltration | LPM, LPGF |
Sterile venting | LPTA |
Final filtration | LPS, LPSD |
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