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isolator monitoring |
Question:
How the “SAS Isolator” microbiological air sampler is connected inside the isolator?
Answer:
The “SAS Isolator” is connected inside the isolator in 3 different ways: >>>
• Configuration A
The isolator wall has already a cable pass-through hole.
• Configuration B
The isolator wall must be drilled and the installed cable can be removed.
• Configuration C
The isolator wall must be drilled and the installed cable is fixed to the wall.
♦ The main unit control cable has a standard length of 3 metres.
♦ The 87898 extension cable has a standard length of 3 metres.
♦ The 91251 extension cable has a standard length of 3 metres.
♦ The 91250 extension cable has a standard length of 3 metres.
All the cablings can be supplied with a different cable length. The desired length must be specified in the purchase order.
Question:
Why is it suggested to monitor the microbial content inside the isolators using a specific sampler, like SAS Isolator instead of a normal portable sampler?
Answer:
The main advantages of the use of SAS Isolator are:
(a) The aspirating chamber is more compact, in comparison with a normal sampler, and the space saving inside the isolator is very important.
(b) The aspirating head can be easily fixed on the wall or on a column, without disturbing the routine operations inside the isolator.
(c) The aspirating head is stainless steel made and can be sterilized with the normal agents typical of isolator (e.g.: hydrogen peroxide).
(d) It is more simple and convenient for the operator to insert the contact plate or the Petri dish inside the aspirating chamber.
(e) The printing of the sampling cycle is obtained without taking out the instrument from the isolator.
(f) More aspirating heads can be commanded by a single command unit.
Question:
“Time is money”. How to reduce the microbiological sampling time of air?
Answer:
The sampling time for 1.000 litres of air (1 cubic metre) using a SAS Super 180 or SAS ISO 180 or SAS Isolator 180 air sampler is 5 minutes and 20 seconds.
Using a sampler Duo-SAS-360 the time is reduced to approx. 3 minutes.
Question:
Which are the main advantages of the use of “SAS Isolator” microbiological air sampler inside the isolators?
Answer:
The main advantages of “SAS Isolator” are easily summarized:
(a) The “SAS Isolator” use the same principle of the very well known “SAS Surface Air System”.
(b) The only connection between the aspirating chamber (inside the isolator) and the command unit (outside the isolator) is an electric cable. No vacuum tubing! No valves!
(c) The aspirating chamber (inside the isolator) is totally made in stainless steel and suitable to be sterilized by hydrogen peroxide or other agents.
(d) The stainless steel aspirating chamber is very compact and can be fixed on the wall, the floor, the ceiling of the isolator where it is more convenient for the operation.
(e) A single command unit (outside the isolator) can work with several aspirating chamber in separate isolators.
(f) It can be used with standard standard 55 mm Contact Plates or standard 90 mm Petri dishes.
(f) All sampling parameters can be printed or transferred to a P.C.
Question:
Which are the suitable connectors for the “SAS-Isolator” microbial air sampler about the pass through walls in the isolator?
Answer:
Different options are reported in the Application Note No.99/85 >>>
Question:
Which are the particles & microbiological limits in Clean oom according EU GMP Annex ! February 2008?
Answer:
| | AT REST | IN OPERATION | | GRADE | MAX PARTICLES >/= STATED SIZES | MICROBIOLOGICAL | | | 0.5µ 5.0µ 0.5µ 5.0µ Air Sample 90 mm settle
cfu/m3 plate cfu/4hr | | A | 3 520 20 3 520 20 < 1 < 1 | | B | 3 520 29 352 0000 2900 10 5 | | C | 352 000 2900 3520 000 29000 100 50 | | D | 3520 000 29000 nd nd 200 100 |
Question:
Where to find useful information for the microbiological monitoring inside an isolator?
Answer:
The May 2009 issue of the PBI Laboratory Gazette “Air Monitoring in Isolator” presents five Application Notes and six Frequent Asked Questions on this subject.
Question:
What is the total surface of the “SAS Isolator” microbiological air sampler to calculate the amount of disinfectant to use during the sterilization step?
Answer:
The total surface of the “SAS Isolator” to be treated is about 1700 cm².
Question:
How long it takes to sample 1 cubic metre of air (1.000 litres) inside an isolator? | | | | | |
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