[PHA6114 lab] Experiment 11 Flashcards
Program the evaluates the cleanliness of the manufacturing or process environment
Environmental Monitoring
Effectiveness of cleaning and disinfection programs and the operational performance of environmental controls
Environmental Monitoring
Environmental Monitoring is divided into two, what are those?
Viable monitoring and Non-viable monitoring
Type of monitoring for air-borne particles
Non-viable monitoring
What range of sizes are read in non-viable monitoring?
0.5 to 5.0 μm
Device use for non-viable monitoring
Optical particle counter
These are used to determine the air quality by counting and sizing the number of particles in the air
Particle counters
Type of monitoring for detection of levels of bacteria and fungi present in defined locations/areas during a particular stage in the activity of processing and filling a product
Viable monitoring
What type of microorganisms are detected in viable monitoring?
Mesophilic microorganisms because they are more common in room temp or body temp
T or F: Some manufactures may have other requirements to examine for other types of microorganisms
True
Ex. anaerobes if nitrogen lines are used
When is viable monitoring normally performed?
“in operation” - meaning, during the manufacturing process as this represents a more realistic assessment of the challenge to the manufacturing process
It involves the collection of data relating to the numbers of microorganisms present in a clean room or clean zone
Microbiological environmental monitoring
Microorganisms in MEM are recovered from the following:
surface, air, people
A physical test which functions has often resided with the microbiology department to perform and due to the theoretical relationship between high numbers of nonviable particles and viable counts
Nonviable particle counting
What is the main aim of MEM?
Assess the monitoring of trends over time and the detection of an upward or downward movement within clean areas
Enumerating the numbers of microorganisms present in a clean room by collecting results using sample types
Viable count aspect of Environmental Monitoring
Different types of Collection for Viable Count aspect of Environmental Monitoring
Passive air-sampling: settle plates (SDA)
Active air-sampling: volumetric air-sampler
Surface samples: contact plates, swabs
Finger plates
Plates of sleeves/gowns
Types of Monitoring Methods
- General purpose medium
- 2 Different culture media used at two different temperatures
What is the general purpose medium?
Tryptone Soya Agar (TSA) at a dual incubation of 20-25 and 30-35 degrees
T or F: Choice of culture media, incubation times, and temperatures do not require validating
False, it requires validating
T or F: Emphasis should always be upon environmental control rather than environmental monitoring
True
T or F: Where a risk is identified, the risk should be minimized as a part of strategy of bringing the clean area into tighter control
True
What should you do if a risk cannot be minimized but continues to exist
Carefully targeted monitoring should be undertaken and the data reviewed, and examined for trends by a registered and professional microbiologist
T or F: Designing facilities in an optimal way is a part of environmental control and where environmental monitoring becomes a tool in the assessment of control
True
