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86 - Indoor air filtration system microbial monitoring
The filtration system of building should be regularly monitored to be sure they are not broken or uncorrectly fixed or contaminated. The HVAC (Heating Ventilation, Air Conditioning) may be responsible for the production and spread of airborne micro-organisms in buildings. The reason of this test is to guarantee the health of rooms, laboratory, hospital and building occupants. The reported “SOP” (Standard Operating Procedure) can help the building servicing engineers in their task. The principle of the test is the comparation of the outdoor microbial population (upstream) with the indoor of the building after filtration (downstream).
Learn more85 - Compressed gas in pharma facilities. Microbial monitoring
Compressed gasses are used at different stages of the pharmaceutical manufacturing process for numerous applications. Compressed gas sampling for microorganisms is an important part of contamination control assessment. Compressed gases such as air, nitrogen and carbon dioxide are deployed in operations involving purging or overlaying. Aside from air, nitrogen is the most commonly used gas in the pharma sector.
Learn more84 - USP 1116 for Microbial Air Monitoring – OOS (Out Of Specifications) and OOT (Out Of Trends)
GLOSSARY Bioburden, alert limit, action limit, corrective action, CFU, Environmental isolates, Environmental Monitoring, genus, microbial identification, OOS, OOT, species, trend. INTRODUCTION The USP Pharmacopea Inspectors request that the trend variation in a Cleanroom or RABS or Isolators in Pharma production should be seriously considered when "alert" and "action" levels are detected.
Learn more83 - TRIO.BAS MINI BLUETOOTH Microbial air sampler – Barcode Brief instructions
BARCODE 1D, 2D USE for TRIO.BAS microbial air samplers The use of barcode ID in microbiological air monitoring procedures can help to save time, to better control the activity of the operator and to achieve a complete traceability of the test. The microbial air sampler preparation The air sampling instrument should be completed with a Bluetooth barcode reader and users and places should be identified by barcode tag / labels. Instrument itself is identified by a s/n written into the microcontroller memory.
Learn more80 - Glossary according USP 38
GLOSSARY FOR MICROBIOLOGICAL AIR ENVIRONMENTAL MONITORING Microbiology according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments - Page 1201, 1202. Airborne Particulate Count – The total number of particles of a given size per unit volume of air. Airborne Viable Particulate Count – The recovered number of CFU per unit volume of air. Air Changes – The frequency per unit of time that the air within a controlled environment is replaced. The air can be recirculated or totally replaced.
Learn more79 - Culture medium and diluent USP 38
CULTURE MEDIA AND DILUENTS – SELECTION OF GROWTH MEDIA IN CLEANROOMS, RABS, ISOLATOR Microbiology according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments - Page 1201, 1196. – Culture media and diluents. The type of medium, liquid or solid, used for sampling or plating microorganisms depends on the procedures and equipment used. Any medium used should be evaluated for suitability for the intended purpose. The most commonly used all purpose solid microbiological growth medium is soybean casein digest agar. As previously noted, the medium can be supplemented with chemicals that counteract the effect of various antimicrobials.
Learn more78 - Microbial isolates identification accordingUSP 38
IDENTIFICATION OF MICROBIAL ISOLATES Identification according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments - Page 1201. A successful environmental control includes an appropriate level of identification of the flora obtained in sampling. A knowledge of the flora in controlled environments aids in determining the usual microflora anticipated for the facility and in evaluating the effectiveness of the cleaning and sanitation procedures, methods, agents and recovery methods. The information gathered by and identification program can be useful in the investigation of the source of contamination, especially when recommended detection frequency are exceeded.
Learn more77 - Isolators, glove boxes, RABS, C-RABS: what are they and what are the differences?
Isolators, glove boxes, RABS, C-RABS: what are they and what are the differences? In this article we try to shed light on the different containment systems for highly active substances Glove boxes: To avoid contamination of the product, the environment or the operator They are the simplest containment systems and serve to prevent contamination of the material to be manipulated, the surrounding environment and the operator.
Learn more74 - Routine monitoring of air quality required in areas used for compounding sterile preparations
On January 1, 2004 Chapter <797>, of the United States Pharmacopeia/National Formulary (USP27/NF22) entitled “Pharmaceutical Compounding Sterile Preparations”, became effective. USP Chapter <797> details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all practice settings in which sterile preparations are compounded. Since USP Chapter <797> is considered a requirement, pharmacies may be subject to inspection for compliance with these standards by state boards of pharmacy, the FDA, and accreditation organizations, such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Accreditation Commission for Health Care, Inc. (ACHA) and the Community Health Accreditation Program (CHAP).
Learn more71 - TRIO.BAS GAS Microbial content in compressed air and gas – SOP Document
MICROBIAL CONTENT IN COMPRESSED AIR AND GAS – SOP DOCUMENT Introduction The following SOP is a guide line to prepare a local SOP for the test of compressed gas or air used in Clean Room. Standard Operating Procedure OBJECT Quantitative bioburden collection in compressed gas lines in Clean Room.
Learn more65 - Microbial air monitoring in Isolators
Monitoring of atmosphere inside isolators is very critical in maintaining high quality standards. In fact there are risks in using portable environmental samplers because they must be introduced each time you sample. “TRIO.BAS Isolator” from ORUM International in Milan is a dedicated instrument for this application. 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 more64 - Full traceability
GAP (Good Air-Monitoring Practice) in Clean Room: Full Traceability The Good Manufacturing Practice and Pharmacopeial request that all the data collected during the microbial air monitoring are registered with full traceability. The TRIO.BAS air samplers include the Barcode 1D or 2D or the Radio Frequency Identification System (RFID) to collect air volumes, date, hours, operator name, location name, plate identification. All these data cannot be modified according to the official inspectors request.
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