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36 - The advantages of the use of a 3 heads air sampler in Clean Room
The TRIO.BAS microbial air sampler has been developed specifically for Clean Room. Several are the advantages.
Learn more34 - Positioning of microbiological air samplers in Clean Room and Controlled Environment
The “TRIO.BAS” microbiological air samplers have the possibility to use different holders and tripods for different positioning (vertical, horizontal, oblique). The “TRIO.BAS” may also be used in horizontal or vertical positions without the use of holder or tripods, due to their shape. The environmental microbiologist should chose the system that best covers his needs in his specific environment.
Learn more33 - Correct aseptic sampling during air sampling monitoring
The correct sampling is fundamental to avoid a microbial contamination with possible wrong results at the end of the analytical process. It is for this reason that all the staff involved in the sampling process should be trained. We are reporting some Guide Lines that should be distributed and explained to all involved personnel.
Learn more31 - Performances of TRIO.BAS air sampler according ISO 14698
Airborne, Alert Level, As-built, AT-Rest, Bacteria, Bio-contamination, Cleaning, CleanRoom, Contact Plate, Controlled Environment, Culture Medium, Disinfection, Micro-organisms, Impact-Sampler, Risk Zone, Sampling Devices, Sampling Plan, Sterilization, Unidirectional Air Flow, Validation, Viable Particles.
Learn more28 - USP Regulation 797 for sterile compounding
Issued by the non-pro t US Pharmacopoeia (USP) and endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), “USP Regulation 797” is the rst enforceable standard for sterile compounding. Originally enacted on January 1, 2004, the latest version became of cial on June 1, 2008. “USP 797” is a broad regulation that covers a variety of pharmacy policies and procedures. It is designed to reduce the number of patient infections due to contaminated pharmaceutical preparations.
Learn more21 - Air Sampling Standard According ISO 14698
The FDA Process Analytical Technology (PAT) requires a more efficient and reliable microbiological air monitoring system. The ability to check and to identify possible microbial contamination during the production and process enables companies to take more quick appropriate and immediate measures to avoid economic losses. The new generation of microbiological air samplers and new monitoring procedures improve the efficiency of the measurement of the microbial air quality in clean rooms and controlled areas.
Learn more18 - Compressed air microbiological monitoring
The present Application Note intends to be a simple Guide Line for the operators involved in the compressed air monitoring applying the ISO 8573-7. The ISO 8573 consists of nine different parts: 1. Contaminants and purity classes. 2. Test methods for aerosol oil content. 3. Test methods for measurement of humidity. 4. Test methods for solid particle count. 5. Test methods for oil vapour and organic solvent content. 6. Test methods for gaseous contaminant content. 7. Test method for viable microbiological contaminant content. 8. Test methods for solid particle content by mass concentration. 9. Test methods for liquid water content.
Learn more16 - Stainless Steel Aspirating head for microbiological air sampler
The stainless steel sampling heads for Contact Plates (RODAC) or Petri dishes are manufactured of AISI stainless steel and are drilled with holes 1 mm in size. The operators can interchange these heads with no difference in air flow on an air sampler regardless of which head is used, as long the recommended procedures below are followed.
Learn more14 - Standard Operative Procedure for Microbial Air Sampling in Clean Room
It is important to organize a correct and clear sampling plan when several clean rooms or controlled contamination areas are to be monitored at the same time for microbial bioburden. To reach this goal it is necessary to have a suitable set of air samplers and a specific SOP that gives to the operators all the information to avoid mistakes and / or misunderstanding. The reported Standard Operating Procedure (SOP) can be used as a guide to be adopted to each individual case.
Learn more10 - Airborne microbial Challenge Test for pharma packaging integrity
Many references describe airborne microbial challenge test to evaluate the possible contamination of pharmaceutical packages due to improper filling or sealing. This Application Note intends to present the general Guide Lines as suggested by PDA.
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