Technical support

With around thirty years of experience in the field of ultra-cleanliness and sterile, STERIGENE strives to offer products and services in line with customer needs. ISO 9001 since 1994, the well-established quality approach at STERIGENE is synonymous with efficiency and safety.

 

Specialist in the advice, installation and commissioning of production process equipment (sterilization autoclave, GMP washer, pharmaceutical filling line, automatic candling machine, candling table, etc.) we also monitor them with our after-sales service (predictive maintenance, spare parts management, preventive maintenance, revamping etc.).

 

From needs analysis, staff training, stock management of consumables to the provision of complete solutions for clean rooms (clean room equipment, airlock furniture and clean room installations), STERIGENE is able to help you propose solutions that respond to your problems.

 

Supported within the SYNEXIN group by STAURATEC, an expert in the validation of controlled atmosphere zones, STERIGENE can offer all the products and services linked to clean rooms, with a controlled atmosphere.

TECHNICAL WASHING PROCESS

GMP pharmaceutical washing is a validable and repeatable process aimed at cleaning a load. The aim of this treatment is to obtain decontamination via washing process equipment.

CLEANLINESS INSURANCE

Cleanliness assurance: Analysis of dirt and contaminants before design and definition of needs.

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cGMP WASHING METHODS

The efficiency of washing with a pharmaceutical washer results from the chemical and mechanical actions of the product.

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GMP WASHING STANDARDS

AFNOR and EUROPEAN washing standards and standards linked to STERIGENE’s activity.

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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.

STERILIZATION METHODS

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

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WATER VAPOR: HEAT TRANSFER ASPECT

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

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REGNAULT TABLE

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

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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.

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LETHALITY TABLE

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

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STERILIZATION STANDARDS

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

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TECHNICAL PROCESS FOR PURE FLUIDS

There are many pure fluids in the pharmaceutical industry. From steam to pure water to water for injection, process equipment for producing pure fluids uses different methods.

PURE WATER PARAMETERS

Compliance and parameters of the European Pharmacopoeia & US Pharmacopoeia of pure waters

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WATER QUALITY

Minimum water quality accepted for pharmaceutical industry products.

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THE DIFFERENT STEAMS

Comparison table of different vapors: industrial, filtered, clean, white and pure.

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PURE FLUIDS STANDARDS

AFNOR and European standards on the production of pure fluids linked to STERIGENE.

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TECHNICAL PROCESS FOR PRODUCT INTEGRITY

 

Product integrity has become increasingly important in the pharmaceutical industries. The aim is to ensure, during product production, the perfect integrity of the contents and the container and the perfect traceability of the batch.

MIRAGE & VISUAL INSPECTION

The candlers allow visual inspection of defects in containers and contents of liquids (particles and appearance defects) and detect leaks in ampoules, vials, cartridges, syringes. STERIGENE has manual candling, semi-automatic candling and automatic candling solutions for the visual inspection of your products.

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BARRIER TECHNOLOGIES

These barrier technologies (insulators & RABS) make it possible to separate the product, the operator and the environment by a combined system of physical and dynamic barriers. To make the right choice between insulators, open RABS or closed RABS, take advantage of STERIGENE’s expertise and let yourself be guided.

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A SET OF EXPERTISE TO (RE)DISCOVER

PROCESS EQUIPMENTS

AFTER-SALE SERVICES

CLEANROOM EQUIPMENTS

CLEANROOM FURNITURES

TECHNICAL SUPPORT