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124 - Cleanroom Microbial Air Monitoring with Operative Efficiency by TRIO.BAS Air Sampler
The Cleanroom monitoring is a continuous program to evidentiate control and detect possible excursions in the environment of aseptic manufacturing area. The choice of location of the air samplers and frequency is based on risk evaluation driven by the nature of cleanroom activity, equipments and process workflow.
Learn more115 - Protocol of Dressing in Cleanroom
The correct dressing of operators in controlled contamination environment is a key point to guarantee the lowering of the particle and microbial count to requested values. This aim is achieved by adopting a well-de ned procedure. One example is suggested by Philip Austin, resumed in the publication “Modular Cleanroom "Terra Universal Vol. 10. N. 3. It illustrates proper donning step-by-step itinerary.
Learn more114 - The Gamma Irradiation
Gamma rays are a form of electromagnetic radiation-like x-rays, but with higher energy. The primary industrial sources of gamma rays are radionuclide elements such as Cobalt 60, which emit gamma rays during radioactive decay. Gamma rays pass readily through plastics and kill bacteria by breaking the covalent bonds of bacterial DNA. They are measured in units called kiloGrays (kGy). Gamma irradiation provides a number of bene ts in cost and sterility assurance. It can be applied under safe, wellde ned, and controlled operating parameters, and is not a heat- or moisturegenerating process. Consequently, there is no heat stress and condensate drainage or outgassing is not required. Most importantly, there is no residual radioactivity after irradiation.
Learn more113 - Do’s and Dont’ts in aseptic practices
Cleanroom environments are not sterile as long as people populate them. The only viable approach is to have people gowned properly and strictly adhere to good aseptic practices and techniques.
Learn more112 - Use of “Daily Shift” Sterile Aspirating Head for TRIO.BAS Air Samplers in Cleanroom
The “Daily Shift” head sterile aspirating head avoids the sterilization of the stainless steel head of the air sampler. It saves time and it certi es the sterilization with an of cial document. This document is requested by the regulatory authorities. The double irradiated sterile packaging allows you to have always available aspirating head ready for use. A single head is used during a complete daily working cycle in clean room. The transparency of “Daily Shift” head is useful to verify that th culture plate is inserted into che aspirating chamber. The plastic of the “Daily Shift” is reciclable.
Learn more111 - Applied microbiology in Cleanroom
Air samples are quantitatively accurate. Microbiology is an exact science. Contamination detect by an active air samplers means that the product made at the same time is contaminated. Air sampling devices are generally equal in their ability to detect contamination. Statistic + sampling plan analysis are suf cient to enable the manager to create a formula for determining “accept/reject” of a product lot. Microbes will survive forever in a cleanroom unless killed by a disinfectant.
Learn more110 - Test questions related to working activity in Clean Room
Essential Basic Vocabulary: Assurance, aseptic, aseptic environment, aseptic processing, bacteria, bioburden, cleanroom. Class, contamination, disinfectant rotation, disinfection, endotoxin, HEPA lter, Laminar ow, media ll, mold, pyrogen, sanitation, sterility assurance, terminal sterilization, unidirectional flow. Identify the criteria required for facilities and type of equipment used in an aseptic environment.
Learn more104 - Data Integrity Good Practice in Microbial Environmental Monitoring
The following ten suggestions will help you to guarantee the integral application of the DIGP (Data Integrity Good Practice) in microbiological Environmental Monitoring.
Learn more91 - Standard Operating Procedure for TRIO.BAS ISOLATOR
Three stainless steel satellite aspirating chambers, with long connecting cable, can be positioned in different locations and commanded from outside by a single unit. The satellite aspirating chamber is compatible with the most commonly used sterilizing agents. Contact plates (RODAC) or Petri dish can be used.
Learn more90 - The interval time programmed air sampling in isolator and RABS by TRIO.BAS DUO and TRIO
The sampling aspirating chamber of “TRIO.BAS Isolator” is compact, manufactured in stainless steel; the command – control unit is separated and positioned outside from the isolator. The compact design save space inside the isolator. The connection is only for power and doesn’t compromise the isolator integrity. No vacuum, valves and s/s tubing are involved. The use of “Shift Head” sterile certified aspirating head simplify the daily activity and reduce contamination risk. Three independent separated aspirating chambers are connected to the central command unit.
Learn more89 - TRIO.BAS ISOLATOR microbial air sampler technical details
THE TRIO.BAS ISOLATOR MICROBIAL AIR SAMPLERS TO BE USED IN ISOLATORS OR RABS HAS INNOVATIVE FEATURES: a. Up to three independent aspirating heads (called satellite units) can be used for three sampling cycles in three different isolators or in the same isolator with different culture medium. b. The connection between the comand unit and the satellite units is via a simple electric cable. c. No conduits or valves to interfere with the daily activity. d. Bluetooth capability for sampling data transfer. e. The use of sterile “Daily Shift Head” reduces the risk of contamination.
Learn more87 - Useful information about Pharmaceutical Environmental Microbiology
How do you set Alert and Action Levels in Environmemtal Microbiology? Most companies have chosen a harmonized approach using the recommendations from the EU and the FDA, to include applying the most stringent criteria where applicable, although some companies stated that they use the most stringent criteria across the board. However, the regulators prefer to see Alert and Action Levels based on historical data once the EM program has been established for a minimum of 12 months.
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