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Sterilization for pharmaceutical industry

09/05/19

When we talk about the sterilization in the pharmaceutical industry, we refer to a large installation, generally bespoke to fully meet this field requirements. The proposed sterilization solutions to pharmaceutical companies are normally endowed with advanced technologies, and numerous ancillary equipment, as well as a specific control system.

 

The sterilization, an essential process in the pharmaceutical industry

As much for the drugs as the MD and other pharmaceutical devices, they should be properly sterilized to guarantee their quality and safety. Indeed, the commercialized products sold by the pharmaceutical industry are usually subjected to very strict regulations and standards with the purpose to ensure the safety of our health. Then the pharmaceutical companies have to take seriously this phase during their production. There are various sterilization methods:

  • Heat: Steam, Dry heat,…
  • Chemical sterilization: Ethylene oxide gas sterilization, Hydrogen peroxide,…
  • Irradiation: Gamma radiation, e-beams

According to the type of product to sterilize and their physical characteristics, some sterilization processes are more appropriated than others. It is therefore important to choose the correct sterilization process.

 

Horizontal steam sterilizerThe different sterilization processes

Below, the most conventional sterilization methods:

  • Pure steam sterilization: undoubtedly the most common method. This sterilization method is perfect for a large numerous of product as surgical instruments, open vial ,…
  • Superheated water sterilization: It is used for the sterilization of closed recipients (usually plastic) with liquid and that cannot withstand thermal shocks like, IV bags, …
  • Gamma Irradiation: It is a radioactive method, based on nuclear fusion. It is used for the sterilization of packaged products, cosmetics, implantable medical devices, …
  • Ethylene oxide sterilization: It is a gas with a high diffusion coefficient, very efficient process to sterilize at low temperature, and used for medical devices, polymer resin-based products, procedure kits, …

 

  

Industrial autoclave

Many pharmaceutical products (dressing, drips, syringes, drugs, intravenous solutions …) have to be sterilized and treated according to the, very radical European and international standards.

They are autoclaves with industrial dimensions, but also designed to perfectly meet all the sector standards and requirements.

The sterilization equipment manufacturers have to be able to design, manufacture, validate and install the industrial sterilizer safely. These are complex and large projects that should be carefully and conscientiously managed from the very beginning until the end. These pharmaceutical sterilizers are very different from the laboratory one, as especially in terms of dimensions, regulations, efficiency and quality.

 

EtO sterilizer manufacturer

The Ethylene oxide sterilization is one of the most efficient and reliable process, and it is used by the pharmaceutical industry, thanks to its very good results in a large number of medical devices and pharmaceutical products. The Eto sterilization equipment have evolved, and nowadays they include new technologies and innovation for a safer and more controlled eto sterilization process.

Our ETO sterilization solution

EtO sterilization chamber by RSDWe offer an ETO sterilization solution completely designed for the pharmaceutical industry. Our turnkey ETO sterilization solution includes:

  • Chamber with jacket and air recirculation
  • Vacuum pump and vaporizer skids
  • Preconditioning and degassing cells
  • Steam generator
  • Gas room
  • Air Purification system
  • Control room

 

 

Our design, manufacturing and qualification are in accordance with the GMP standards, ATEX zone classification and all applicable regulations. Besides, we have developed a control system based on SCADA technology, and programmed according to our strict HAZOP, and based on a SIL analysis for each single project.

ETO sterilization validation

The ETO sterilization process is composed of the following phases:

  • Conditioning / preconditioning
  • Sterilization
  • Degassing / aeration

It is important and essential to get a correct validation of the sterilization process in order to release the products on the market. But this ethylene oxide sterilization validation has also an impact on the sterilization equipment. That’s why all the quality protocol phases coming from the validation plan have to be executed and correctly written (FAT, IQ, OQ, DQ, …). 

The ETO sterilization facilities are numerous in the pharmaceutical industry. The companies always look for innovative, efficient and safe solutions that can be adapted to their production needs. Needless to say that the industrial sterilization projects have to be managed by experts in order to get optimal results, leading to high quality installations.