Systec GmbH is a manufacturer of laboratory sterilizers, autoclaves (steam sterilizers), media preparators and dispensing devices for liquid media and microbiological culture media.
Systec develops and manufactures, certified according to ISO 9001 and ISO 14001, a wide range of products for the modern laboratory, science and research as well as biotechnology, pharmacy, quality control and production.
Systec autoclaves can be used in all laboratory applications, including challenging sterilization processes: Sterilizing liquids (such as culture media, nutrient media), solid bodies (such as instruments, pipettes, glassware), waste (sterilization of liquid waste in bottles or solid waste in waste bags before destruction), and biologically hazardous materials in safety laboratories.
All Systec autoclaves can be expanded with options and equipment on a modular basis, in order to optimize your sterilization process and implement validated sterilization processes. Companies can select only the options they need to optimize their specific sterilization procedure.
Horizontal bench-top autoclaves Systec D-Series
The Systec D-Series are front-loading, bench-top autoclaves available in 7 sizes with chamber capacities ranging from 23 to 200 l. Compact on the outside but with ideal chamber capacities inside. Each size has an optimal loading capacity for most standard media bottles and Erlenmeyer flasks.
Vertical floor-standing autoclaves Systec V-Series
The Systec V-series of top-loading vertical autoclaves in 8 different sizes with 40 to 150 liters chamber volume is distinguished by its small footprint and high chamber capacity. Result: optimal loading capacity with most standard media bottles and Erlenmeyer flasks.
Horizontal floor-standing autoclaves Systec H-Series
The Systec H-Series floor-standing autoclaves of the performance category HX can be used for all laboratory applications, even for sophisticated sterilization processes and are available in 16 different sizes with 65 to 1580 liters chamber volume. All additional optional accessories can be fitted to obtain validatable processes. In spite of the high loading capacity, these autoclaves are compact and have a comparatively low weight.
Sterilization of liquids, solids, waste in disposal bags and hazardous biological substances
Sterilization that is easy, safe, accurate, reproducible and validatable.
The sterilization process in an autoclave can be rather difficult. For example, when sterilizing liquids or solids (instruments, glassware, filters or textiles) for later use in the lab, the sterilization process must ensure to produce a sterile product, reproducible at any time. Products sterilized for use in labs cannot be tested for sterility, as this would contaminate them again and thus they could not be used in the lab any longer.
Validation of steam sterilization processes has become an increasingly important issue to ensure reproducible results that can be verified. Furthermore, safety aspects must generally be considered when autoclaving, and in particular when sterilizing liquids. Sterilization is generally done at a temperature of 121⁰C.
This corresponds to a steam pressure of approx. 2 bar. Such high temperatures and the ensuing pressure may pose considerable risk potential for the operator, if the autoclaving process has design flaws or is not executed properly.
Systec GmbH’s new product brochure is available right now. The brochure has been redesigned and provides an overview of our wide product range of autoclaves and media preparators.
According to the EU-GxP guidelines, systems and processes that are directly involved in the manufacturing process for product groups such as pharmaceuticals, active ingredients, cosmetics, food, animal feed, and medical devices and thus have an influence on product quality must be qualified and validated. The requirements of the Guide to Good Laboratory Practice are addressed at laboratories conducting non-clinical studies on test objects such as pharmaceuticals, pesticides, biocides, cosmetics, veterinary medicinal products, food additives, feed additives, and industrial chemicals. Systems and processes used to inactivate human sample materials (body fluids, tissues, cell cultures, etc.), microorganisms, cell cultures, endoparasites – including their genetically modified forms – also fall under this category.
A requirement of the principles of good laboratory practice is that equipment, including validated computer-aided systems used to collect, record, and reproduce data and to control the environmental conditions relevant to the test, must be of adequate design and performance. If your autoclave is directly involved in studies on the above-mentioned product groups, its suitability in terms of design and performance must be proven. In detail, the supervisory authorities will define the requirements for qualification and validation implementation and documentation in more detail by specifying standards, guidelines, etc. or they may follow standards because the standardisation also moves within certain limits.
Qualification and Validation
As an autoclave operator involved in your manufacturing process – or as a laboratory operator – you are responsible for your manufacturing process or for the results and conclusions of your study. Qualification and validation is often carried out with the help of an appropriately qualified service provider. Since only you can define the product-specific requirements for your process, close cooperation between your specialist departments, the qualifier/validator, and the autoclave manufacturer is necessary.