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air hand and surfaces |
Question:
Which are the microbiological parameters to evaluate in the indoor office premises using the “SAS” air sampler?
Answer:
-Introduction
Three are the parameters that should be investigated:
Psycrotrophic Total Bacterial Count
It is an indicator of the environmental bacterial contamination. In fact the psycrotrophic bacteria have an ideal growing temperature of about 25°C (15°-30°C) and they use the organic material present in the soil, vegetables and prefer humid environments.
Mesophylic Total Bacterial Count
It is an indicator of animal or human contamination. In fact the mesophylic population has an ideal growing temperature of about 37°C (25°-40°C) and also includes the traditional pathogens.
Moulds and Yeasts Total Count
It is an indicator of the poor quality of indoor ventilation (air conditioning, heating, filters).
-The European Index
The European Collaborative Action Report No.12 (1993) gives the following reference index:
Total Bacterial Count
| Bacterial Population | CFU/cubic metre
Industrial Environments | CFU/cubic metre
Non Industrial Environments | | Very Low | < 100 | < 50 | | Low | < 500 | < 100 | | Interm. | < 2,500 | < 500 | | High | < 10,000 | < 2,000 |
Yeast and Mould Count
Yeast and Mould
Population | CFU/cubic metre
Industrial Environments | CFU/cubic metre
Non Industrial Environments | | Very Low | < 50 | < 25 | | Low | < 200 | < 100 | | Interm. | < 1,000 | < 500 | | High | < 10,000 | < 2,000 |
-Microbial Identification
It is necessary in some cases to perform the microbial identification. Examples are Legionella or moulds (Cladosporium, Penicillium, Aspergillus, Fusarium, Cryptococcus neoformans).
-The instrumentation for the microbiological sampling of air
It is used the “SAS ISO”.
Question:
What is the maximum volume of air to be aspirated by the impact air sampler on the same agar plate without to compromise the micro-organism growth?
Answer:
The loss of moisture during sampling time can dehydrate the nutrient medium and give non ideal conditions for the micro-organisms growing. The results reported in the Application Note N.99/90 and N.99/92 show that the loss of moisture using the “SAS” air samplers do not compromise the micro-organisms multiplication.
Question:
Which are the microbiological environmental limits in the controlled environments?
Answer:
Grade A
It is the area for high risk operations - Class 100 in operation USP/FS 209E and Class ISO 5 UNI EN ISO 14644-1.
EU GMP Limits
Dinamic Air: < 1 CFU / cubic metre of air
Sedimentation Air: < 1 CFU / plate / 4 hours
Surfaces: < 1 CFU / 25 square centimetres
Operators: < 1 CFU / glove
Grade B
It is the area around the Grade A - Class 100 at rest and 10.000 in operation USP/FS 209E.
EU GMP Limits
Dinamic Air: 10 CFU / cubic metre of air
Sedimentation Air: 5 CFU / plate / 4 hours
Surfaces: 5 CFU / 25 square centimetres
Operators: 5 CFU / glove Grade C
It is the area dedicated to less risk operation - Class 10.000 at rest and 100.000 in operation USP/FS 209E and Class ISO 8 in operation UNI EN ISO 14644-1.
EU GMP Limits
Dinamic Air: 100 CFU / cubic metre of air
Sedimentation Air: 50 CFU / plate / 4 hours
Surfaces: 25 CFU / 25 square centrimetres Grade D
It is the less risk area - Class 100.000 at rest and 100.000 USP/FS 209E
Limiti EU GMP
Dinamic Air: 200 CFU / cubic metre of air
Sedimentation Air: 100 CFU / plate / 4 hours
Surfaces: 50 CFU / 25 square centrimetres
Question:
Which accessories should be used to optimize and simplify the microbiological air sampling inside the Clean Room?
Answer:
-Introduction
New accessories have been developed and produced to facilitate and optimize the use of “SAS” air samplers in Clean Room.
-“Vertical Stand”
Stability system for “SAS” to guarantee a stable vertical position. The “Vertical Stand” is fixed to the air sampler to give the best stability on cart or moving belt. This complete stainless steel construction is ideal for use in Clean Room to avoid particle emission.
- “Clean-Tripod”
Floor tripod, totally made in stainless steel, to collect bioaerosol at the level of breathing
Fixed high at 168 cm
The complete stainless steel construction is ideal for use in Clean Room to avoid particle emission.
-“RODAC Rack”
Stainless steel rack to transfer 55 mm Contact Plates during the sampling cycle.
The complete stainless steel construction is ideal for use in Clean Room to avoid particle emission.
- “Petri Rack”
Stainless steel rack to transfer 90 mm Petri Plates during the sampling cycle.
The complete stainless steel construction is ideal for use in Clean Room to avoid particle emission.
Question:
How to manage the aspirating head of the microbiological air samplers in Clean Room?
Answer:
-Introduction
The aspirating head of the microbiological air sampler should be sterilised before the sampling cycle in the Clean Room.
The FDA and National Health Authorities request the availability of a written document confirming that the head has been sterilised (traditionally by autoclaving).
The stainless steel or aluminium head should be sterilised at 121°C / 15 minutes and a subsequent document prepared and registered / printed for each sampling cycle. This operation is compulsory and time consuming.
The non-availability of the sterilisation document is reason of a non-conformity.
-The sterile “Daily-Head”
The “daily head” tripled packed, plastic, sterile aspirating head is a valid and useful device to help the staff to better invest his time and efforts and to have a written official document to present to the FDA or local Authorities inspectors.
The document reports:
(A) Name of product and Catalogue number
(B) Date of sterilisation
(C) Expiration Date (5 years)
(D) Lot Number
(E) Type of sterilisation
(F) Sterilisation indicator.
Several cycles can be repeated with the same “Daily-Head” aspirating head, in the same Clean Room and during the same working shift.
A new “daily-head” aspirating head should be used when a new working shift starts.
The used “Daily-head” is eliminated together with the plastic material.
-STANDARD OPERATING PROCEDURES
The following text is a guideline for the SOP to be prepared.
¡ TITLE
Use of the “Daily-Head” sterile aspirating head for air monitoring in Clean Room
¡ PURPOSE
To apply the correct cGAP (current Good Aseptic Practice) in air monitoring
¡ GLOSSARY
Aspirating head, Disposable, Sterile, Sterilization
¡ STANDARD
-ISO 14644-1
-EEC-GMP Annex 1 – 2008
-SAS-ISO Instruction Manual
¡ RESPONSIBILITY
Production Manager or Laboratory Manager
¡ MATERIAL
“Daily-Head” sterile aspirating head
Contact plates or Petri dishes
Sterile gloves
Disinfectant sterile spray
¡ PROTOCOL
(1) The “daily-head” is tripled packed to be introduced into the Clean Room according to the usual procedure to avoid microbiological contamination.
(2) The body of the sampler and the aspirating chamber are treated by sterile disinfectant aerosol (70% iso-propilic alcohol).
(3) The sterile filled contact plate or Petri dish is inserted into the aspiration chamber and the lid removed, avoiding is contamination.
(4) The “daily-head” aspirating head is applied to the air sampler.
(5) The volume of air to be aspirated and the sample cycle are programmed (eg.: 500 or 1000 lts of air).
(6) The sampling cycle is executed and, at the end, the “daily-head” is removed and re-inserted in its bag until the next sampling cycle.
(7) The lid is applied to the contact plate (or Petri dish) and transferred into the rack for delivery to the microbiological laboratory.
(8) Several cycles can be repeated with the same “Daily-Head” aspirating head, in the same Clean Room and during the same working shift.
(9) A new “daily-head” aspirating head should be used when a new working shift starts.
(10) The used “Daily-head” is eliminated together with the plastic material. | | | | | |
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