English
Arabic
Chinese simplified
Dutch
French
German
Japanese
Korean
Portuguese
Spanish
Ukrainian
SEARCH
Languages
85 - 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 more82 - Sampling viable organisms by microbial active air samplers
IMPORTANCE OF THE IMPACTION ON AGAR SURFACE. Effect of jet velocity, nozzle size, nozzle distance from the agar surface, quality of medium, volume of medium inside the culture, expiration date of the plate, moisture content and sterility of the medium, temperature should be considered to obtain the optimization of these variables. These facts are determinative to obtain an efficient design of a microbial air sampler. ISO-14698 standard mentions that impaction velocity should be less than 20 metres per second.
Learn more81 - The Bluetooth applications to transfer data from the TRIO.BAS microbiological air sampler
THE BLUETOOTH APPLICATIONS TO TRANSFER DATA FROM THE TRIO.BAS MICROBIOLOGICAL AIR SAMPLER. The Bluetooth applications is an ideal electronic device to transfer the environmental data collected by the TRIO.BAS air samplers.
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 more76 - SOP – Standard Operating Procedure for use, maintenance, calibration of “TRIO.BAS” microbiological air samplers
OBJECT The purpose of this document is to describe the procedure for sampling, and reporting of the viable airborne particulates as part of environmental program, using TRIO.BAS Microbiological Air Sampler. OBJECTIVE This procedure applies to particulate sampling and evaluation of air quality for viable particulates using a Microbiological Air Sampler
Learn more75 - Sequential sampling
SEQUENTIAL SAMPLING WITH TRIO.BAS DUO AND TRIO IN CLEAN ROOM, ISOLATORS, RABS With TRIO.BAS DUO microbial air sampler (with 2 separated aspirating chambers) and TRIO.BAS TRIO microbial air sampler (with 3 separated aspirating chambers) it is possible to monitor two or three different environments or spots of the same environment, simultaneously.
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 more
