Pharmaceutical Sterilization

TECHNICAL STERILIZATION PROCESS

Pharmaceutical sterilization is a validable process aimed at rendering a product free of viable microorganisms. This treatment aims to obtain sterility using a pharmaceutical sterilizer.

CUSTOMER CASE: ISSUES RELATED TO AUTOCLAVE STERILIZATION

 

Discover a complete study and the response provided to an issue that required specific development in order to meet all customer needs.

How did our client maintain its specific sterilization cycle, with the use of SYNEXIN expertise, when changing the autoclave model?

Download our complete study: objectives, tests, development and conclusion.

STERILIZATION METHODS

Different methods are cited and commented on in the international guides relating to Good Manufacturing Practices (GMP) annexed to the respective Pharmacopoeias.

WATER VAPOR: HEAT TRANSFER ASPECT

Steam has several phases: wet steam, saturated or dry steam and superheated steam. Discover the phase diagram.

REGNAULT TABLE

Discover the empirical formula giving the latent heat of vaporization of water (here saturated steam) as a function of temperature and pressure.

STERILIZING VALUE

The sterilizing value “Fo” is expressed in units of time and makes it possible to quantify the effect of a sterilizing treatment during a decontamination process.

LETHALITY TABLE

Sterilization by pharmaceutical autoclave is subject to numerous controls. Discover the lethality table used in the pharmaceutical industry.

STERILIZATION STANDARDS

Standards and guidelines for sterilization and disinfection from AFNOR and the European Pharmacopoeia in connection with STERIGENE’s activities.

A SET OF EXPERTISE TO (RE)DISCOVER

PROCESS EQUIPMENTS

AFTER-SALE SERVICES

CLEANROOM EQUIPMENTS

CLEANROOM FURNITURES

TRAINING & AUDIT