equipment
Specialised Environmental Services uses the finest equipment available for its testing.Biotest’s diagnostics products are registered throughout Europe and a majority of them are registered in the USA as well.
There Biotest is one of only three manufacturers in the field of immunohaematology to have been granted access to the market by the Food and Drug Administration. In their continuing international expansion, too, they will be concentrating on those markets in which suppliers are permitted to operate only if they can meet the highest safety and quality standards.
In parallel, Biotest are strengthening their position in developing countries as well. An important element in this is what is known as contract fractionation agreements with the national blood plasma companies in various countries.
Through an agreement of this sort, for example, they supply Iran, a country of 80 million inhabitants, with coagulation factors and immunoglobulins.
Instruments we use:
Biotest HYCON® offers a wide range of air samplers and particle counters for monitoring Clean Rooms and isolatior areas:
• The air samplers, which work on the centrifugal impaction principle, are characterised by flexibility in their possible applications, gentle and validated sampling technology and high user-friendliness.
• The particle counters are characterised in particular by high efficiency and sensitivity.
• The range is constantly being expanded by new developments such as the RCS Isolator for example.
• The extensive range of agar strips and comprehensive customer service complement the unique offering of the HYCON® instrument line.
Air Samplers
The most secure and effective air sampling system for environmental monitoring. The Biotest air samplers (RCS) that have been well known and esteemed for decades work on Reuter’s tried and tested centrifugal impaction
principle.
Cleanroom and Isolator areas within the pharmaceutical, cosmetic and food & beverage industries have to perform strict environmental monitoring.
This is most important in the sterile areas of the pharmaceutical industry where GMP, FDA, USP and ISO 14698 guidelines have numerous requirements for air monitoring.
These monitoring requirements do not only apply to the ambient air within sterile areas, but also to compressed gasses used in sterile environments.
Only a microbial air sampler capable of fulfilling these requirements can assure a secure and easy microbial monitoring program.
Requirements fulfilled by the RCS High Flow:
• Proven Technology
Centrifugal based sampling.
• Short Sampling Time
Flow rate of 100 Litres/min.
• Flexibility and Mobility
Various features such as user selectable sampling volumes, delayed sampling time and re-chargeable batteries make the RCS High Flow easy to use.
• Validated System Including Pharmacopoeia
Recommended Media
Biotest has developed TCI-? media that neutralizes all commercial disinfectants as stated in the Pharmacopoeia.
• Maximum Sampling Efficiency
Shown by extensive validation studies.
• Optimal Design
Special aerodynamic system diminishes turbulence.
• Sterility Assurance
All components which come in contact with the sampled air are easily disinfected by autoclaving or wiping with commercially available disinfectants.
• Simple Handling
The RCS High Flow is an easy yet effective means for monitoring your critical environments supported by software features (extra functions)
Particle Counters
Biotest offers particle counters for the determination of particulate contamination (for example in Clean Rooms). For ten years, Biotest has been a global leader in the development of airborne particle counters.
Now, Biotest introduces the world´s first portable airborne particle counter to sample with a flow rate of 100 LPM. The APC M3 , built for speed and reliability, offers users significant time savings up to 70% to monitor the cleanroom.
Agar Strips
We use the Agar Strips specifically made for the Biotest HYCON® RCS air samplers. A choice is made from unselective media for total microbial counts and selective media for fungi and yeasts, coliform organisms and for staphylococci. For use in highly sterile situations there are gamma-irradiated
products in a sterile double packs.
All agar strips are welded into a re - sealable sleeve to enable individual strips to be safely sterilised a number of times by peroxide gassing. A new medium is the TCI-, a special medium for total microbial counts in isolatior areas where residues of hydrogen peroxide in the air are to be expected. The new medium, also gamma-sterilised, contains additives which can neutralise more than 5000 ppm of hydrogen peroxide.
