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air hands and surfaces

Question:
How do you transfer the microbiological air sampling data from “Pinocchio Super II” compressed air sampler to a printer or P.C.?

Answer:
The “SAS Super 100” or “SAS Super 180” air sampler is applied to “Pinocchio Super II” and from it, at the end of sampling cycle, using a small collecting cable, the sampling data (progressive number, date, air volume, identification, etc.) are transferred to a printer or P.C.

Question:
Which are the microbial active levels for air and surfaces according to the Microbial Bioburden of USP 797?

Answer:
-Introduction
Issued by the non-profit US Pharmacopoeia (USP) and endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), “USP Regulation 797” is the first enforceable standard for sterile compounding. Originally enacted on January 1, 2004, the latest version became official on June 1, 2008.
“USP 797” is a broad regulation that covers a variety of pharmacy policies and procedures. It is designed to reduce the number of patient infections due to contaminated pharmaceutical preparations.
“USP 797” contains specific requirement for ongoing air and surface evaluation to ensure product sterility and safety for compounded sterile preparations (CSPs).
“USP 797” applies to all staff and environments involved in the preparation of CSPs: pharmacies, hospitals, clinics, medical doctor offices. Less formal procedures are applied in these sectors for sterility safeguard in comparison with drug manufactured that are under strict control of FDA.
-Risk level
“USP 797” classifies the compounding in 3 different levels: Low-Risk level CSPs, Medium-Risk level CSPs, High-Risk Level CSPs.
-Recommended Action Levels for microbial contamination

Viable Air Sampling

CLASSIFICATION	CFU/1000 LITRES OF AIR
ISO Class 5	> 1
ISO Class 7	> 10
ISO Class 8 or worse	> 100

Surface Sampling

CLASSIFICATION	CFU/1000 LITRES OF AIR
ISO Class 5	> 3
ISO Class 7	> 5
ISO Class 8 or worse	> 100

If air or surface microbial contamination action levels are reached, taking immediate action will help to quickly eradicate threats and mitigate risks to patients health.
It may be necessary to consult a microbiologist / infectivologist or industrial hygienist to identify and correct the source of contamination.
-Necessary material for air and surface monitoring
Air:
“SAS Surface Air System” volumetric air sampler
Surfair plate - RODAC Contact plate or 90 mm Petri dish with suitable medium
Surface:
RODAC-Weight surface sampler
Surfair plate - RODAC Contact plate

Question:
Where the “SAS” air samplers are produced?

Answer:
The complete line of the “SAS” microbiological air samplers are produced and calibrated in the Monza factory >>>

Question:
Which aspiration head should be used with the impact type microbiological air samplers like “SAS”?

Answer:
The aspiration heads of the “SAS” microbiological air samplers are produced with 3 different materials: stainless steel, aluminum, plastic resin.
- “Inox-Drilled” Stainless Steel head
It is the “cleanest” head and has a better resistance to the corrosion (Chlorine chemicals exception). The negative point is the weight. It should be sterilized by autoclaving before each sampling cycle. Each sterilization cycle must be certified with a written document to present it to FDA inspectors during their visits.
It is typically used in Clean Room and operating theatre.
- “Drilled” Aluminum head
It is lighter than the stainless steel head.
It should be sterilized by autoclaving before each sampling cycle. Each sterilization cycle must be certified with a written document to present it to FDA inspectors during their visits.
The disinfection using sterile alcohol is applied in non-critical environments.
It is typically used in food, dairy, cosmetic, Indoor Air Quality applications.
- “Daily-Head” plastic resin
It is lighter than stainless steel and aluminum. The advantage is that it is sterilized, identified by lot number, tripled packed for Clean Room, and complete of sterilization certificate to be presented to the FDA inspectors during their visit.
It is typically used in Clean Room.

Question:
Which is the maximum level of CFU / 1000 litres of air I should have in my confined environment?

Answer:
-Introduction
This is a very frequent question because everybody would like to have a precise figure as a reference. It is first of all necessary to classify the type of environment:
- standardized, confined and controlled environment (clean room, sterile room, operating theatre, etc.)
or
- not standardized environment (public offices, private building, restaurant, school, train, etc.).

National and International standards are available for standardized environments

-Clean room (pharmaceutical)
Grade A
Air Dinamic < 1 CFU / 1000 litres of air
Air Sedimentation < 1 CFU / plate / 4 hours
Surface < 1 CFU / 25 square centimetres
Operator < 1 CFU / glove
Grade B
Air Dinamic 10 CFU / 1000 litres of air
Air Sedimentation 5 CFU / plate / 4 hours
Surface 5 CFU / 25 square centimetres
Operator 5 CFU / glove
Grade C
Air Dinamic 100 CFU / 1000 litres of air
Air Sedimentation 50 CFU / plate / 4 hours
Surface 25 CFU / 25 square centimetres
Grade D
Air Dinamic 200 CFU / 1000 litres of air
Air Sedimentation 100 CFU / plate / 4 hours
Surface 50 C FU/ 25 square centimetres

-Operating theatres
WHO Guide Lines

TYPE OF ENVIRONMENT	MICRO-ORGANISM PER 1000 LITRES OF AIR	ENVIRONMENT CLASSIFICATION
Operating theatre Special rooms Special Laboratories	Up to 10 CFU/1000 litres of air	I. Level - Very low environmental bacterial count
Operating theatre of first aid Operating theatre adiacent rooms Sala parto Nido per lattanti Unità centrale di sterilizzazione (“zona pulita”)	Up to 200 CFU/1000 litres of air	II. Level - Low environmental bacterial count
Patient room	Over 200-250 CFU/1000 litres of air	III. Level

National Health Service - Health Technical Memorandum Ventilation in Health Care Premises, ISO 14644 Annex I GMP EU Guide.

Air near the operating table (CFU/1000 litres of air)	“At rest” operating theatre	< 35 CFU / 1000 litres of air
	“In operation” operating theatre with turbulent air flow	< 180 CFU / 1000 litres of air
	“In operation” operating theatre with unidirectional air flow	< 20 CFU / 1000 litres of air
Air from HVAC (CFU/1000 litres of air)		< 1 CFU / 1000 litres of air

-Ultra-Clean Systems
NHS Estates. Executive Agency of the Department of Health – Health Technical Memorandum 2025. Validation and Verification
Protocol
a. The air from HVAC should contain no more than 0,5 CFU/m3 of air.
b. The sampled air near the patient (max 300 mm distance) during the operation should have not more than 10 CFU/ of air (if traditional cotton dresses are used). The CFU/m3 of air should be less than 1 if more sophisticated dresses are used.
c. The air around the “Clean Zone” during the surgical operation should contain no more than 20 CFU/m3 of air if traditional dresses are used (10 CFU/m3 of air if sophisticated systems are used).

A specific graphic should be prepared for non standardized environments. This graphic is then used as a guide line for the considered environment
The occupant density is the key factor influencing the level of airborne bacteria, but humidity is also important depending on the particular location.

-Preparation of the reference graphic
At least 30-60 double sampling cycles should be considered for the preparation of the reference graphic. The sampling should be performed at programmed time (every day or specific days of the week) with the environment in “standard” conditions (same number of occupants, same activity, same temperature and humidity, etc.?
The results should be reported on the graphic (CFU/1000 litres of air) indicading:
a. the “Upper Control Limit” (UCL)
b. the “Lower Control Limit” (LCL)
c. the “average

-Result evaluation
The results can be evaluate in different ways. Examples are here reported.

(A) Single Peak above or below the UCL or LCL
If the result is over the UCL, it is necessary to investigate to understand what happened in the specific time or day to start a possible corrective action.
If the result is lower than the LCL, it is necessary to investigate about the reason of a possible under-estimation due to the un-correct apply of the sampling protocol (volume of air, nutrient medium, incubation, etc.)
(B) Progressive rise trend
If there is a “rise trend” (either over or under the average – e.g.: 3-5 consecutive results -) it is necessary to understand the reason of such tendency.

(C) Trend above the average
If there are 3-5 consecutive results above the average, it is necessary an immediate intervention.
The graphic should be updated every 12-18 months.

Question:
Which are the recommendations to avoid cross-contamination during the manipulation of Contact Plate (RODAC) for air, surface or hands hygiene testing?

Answer:
- “SAS - Surface Air System” Air sampler
(a) Wash your hands according to a specific protocol in use in your organization.
(b) Wear disposable sterile gloves. This procedure is valid in high risk closed environments like Clean Rooms, etc.
(c) Disinfect with 72% sterile alcohol the external surface of the plastic bag containing the filled Contact plates. The type of medium should be according to the specific micro-organisms of interest.
(d) Open the plastic bag and pull out a single Contact plate. Identify it.
(e) Transfer the identified Contact plate to the previous disinfected aspirating chamber of the “SAS” air sampler.
(f) Take off the lid of the Contact plate (and transfer it to a clean surface (e.g.: the protective white plastic cover of the aspirating head or the rigid plastic container of Contact plates or a disinfected surface of the desk). Care to avoid contamination, particularly during this manipulation (the operator should be trained!). It is suggested the “lid facing down” to avoid that dust, particles, micro-organisms can settle on the inside part of the lid.
(g) Apply the aspirating head to the “SAS” air sampler and complete the cycle.
(h) Unscrew the aspirating head, transfer the lid to the Contact plate to cover it, take off the Contact plate and transfer it to the “Contact Plate Carrier” for delivery to the laboratory as soon as possible. Care to avoid contamination, particularly during this manipulation (the operator should be trained!).
Note:
Refer to the Application Note N.99/97 to have detailed pictures of the “SAS” air sampler method of use.
- “RODAC-WEIGHT” surface sampler
(a) Wash your hands according to a specific protocol in use in your organization.
(b) Wear disposable sterile gloves. This procedure is valid in high risk closed environments like Clean Rooms, etc.
(c) Disinfect with 72% sterile alcohol the external surface of the plastic bag containing the filled Contact plates. The type of medium should be according to the specific micro-organisms of interest.
(d) Open the plastic bag and pull out a single Contact plate. Identify it.
(e) Slide in the identified Contact plate to the previous disinfected area of the “RODAC-WEIGHT” surface sampler.
(f) Take off the lid of the Contact plate and transfer it to a clean surface (e.g.: the protective white plastic cover of the aspirating head or the rigid plastic container of Contact plates or a disinfected surface of the desk). Care to avoid contamination, particularly during this manipulation (the operator should be trained!). It is suggested the “lid facing down” to avoid that dust, particles, micro-organisms can settle on the inside part of the lid.
(g) Apply the “RODAC-WEIGHT” to the surface to be sampled and complete the 10 seconds cycle.
(h) Transfer the lid to the Contact plate to cover it, slide off the Contact plate and transfer it to the container “Contact Plate Carrier” for delivery to the laboratory as soon as possible. Care to avoid contamination, particularly during this manipulation (the operator should be trained!).
- “MAXI-Contact Plate” hands sampler
(a) Wash your hands according to a specific protocol in use in your organization.
(b) Wear disposable sterile gloves. This procedure is valid in high risk closed environments like Clean Rooms, etc.
(c) Disinfect with 72% sterile alcohol the external surface of the plastic bag containing the filled “MAXI Contact plates”. The type of medium should be according to the specific micro-organisms of interest.
(d) Open the plastic bag and pull out a single “MAXI Contact plate”. Identify it.
(e) Take off the lid of the “MAXI Contact plate” and transfer it to a clean surface (e.g.: the protective white plastic cover of the aspirating head or the rigid plastic container of Contact plates or a disinfected surface of the desk). Care to avoid contamination, particularly during this manipulation (the operator should be trained!). It is suggested the “lid facing down” to avoid that dust, particles, micro-organisms can settle on the inside part of the lid.
(g) Apply the “MAXI Contact plate” to the fingers or palm of the hand to be tested for few seconds.
(h) Transfer the lid to the “MAXI Contact plate” to cover it, and transfer it to the container for delivery to the laboratory as soon as possible. Care to avoid contamination, particularly during this manipulation (the operator should be trained!).

Question:
Which type of “SAS” microbiological air samplers should you chose in Clean Room?

Answer:
-Introduction
The Clean Rooms need a regular monitoring of the microbiological condition of air according to National and International standards (USA – European – Japanese Pharmacopeia, ISO, etc.)
-The Clean Room microbiological air samplers
The line of Clean Room “SAS” Surface Air System air samplers from international pbi in Milan cover all the need of the Clean Room.

Traditional commonly used air samplers model for Clean Room
(a) “SAS Super ISO 100” - RODAC air sampler portable single unit for Clean Room
It uses a simple Contact Plate. The air flow is 100 litres per minute.
1000 litres of air are aspirated in 10 minutes.
(b) “SAS Super ISO 180” – RODAC air sampler portable single unit for Clean Room
It uses a simple Contact Plate. The air flow is 180 litres per minute
1000 litres of air are aspirated in appr 6 minutes
(c) “SAS Super ISO 100" – PETRI air sampler portable single unit for Clean Room
It uses a simple Petri dish. The air flow is 100 litres per minute
1000 litres of air are aspirated in 10 minutes
(d) “SAS Super ISO 180" – PETRI air sampler portable single unit for Clean Room
It uses a simple Petri dish. The air flow is 180 litres per minute
1000 litres of air are aspirated in appr. 6 minutes

Bar Code air samplers model for Clean Room
(e) “SAS Super ISO 100” - RODAC Bar Code - air sampler portable single unit for Clean Room
It uses a simple Contact Plate. The air flow is 100 litres per minute
1000 litres of air are aspirated in 10 minutes
(f) “SAS Super ISO 180” - RODAC Bar Code - air sampler portable single unit for Clean Room
It uses a simple Contact Plate. The air flow is 180 litres per minute
1000 litres of air are aspirated in appr 6 minutes
(g) “SAS Super ISO 100” - PETRI Bar Code - air sampler portable single unit for Clean Room
It uses a simple Contact Plate. The air flow is 100 litres per minute
1000 litres of air are aspirated in 10 minutes
(h) “SAS Super ISO 180” - PETRI Bar Code - air sampler portable single unit for Clean Room
It uses a simple Contact Plate. The air flow is 180 litres per minute
1000 litres of air are aspirated in appr 6 minutes

Cart on wheels air samplers model for Clean Room
(i) “SAS Super ISO 100” – RODAC Cart on wheels – air sampler portable single unit for Clean Room
It uses a simple Contact Plate. The air flow is 100 litres per minute
1000 litres of air are aspirated in 10 minutes
(l) “SAS Super ISO 180” – RODAC Cart on wheel - air sampler portable single unit for Clean Room.
It uses a simple Contact Plate. The air flow is 180 litres per minute
1000 litres of air are aspirated in appr 6 minutes
(m) “SAS Super ISO 100" – PETRI Cart on wheels air sampler portable single unit for Clean Room
It uses a simple Petri dish. The air flow is 100 litres per minute
1000 litres of air are aspirated in 10 minutes
(n) “SAS Super ISO 180" – PETRI Cart on wheels air sampler portable single unit for Clean Room
It uses a simple Petri dish. The air flow is 180 litres per minute
1000 litres of air are aspirated in appr. 6 minutes

Wall air samplers model for Clean Room
(0) “SAS Super ISO 100” – RODAC wall – air sampler portable single unit for Clean Room
It uses a simple Contact Plate. The air flow is 100 litres per minute.
1000 litres of air are aspirated in 10 minutes.
(p) “SAS Super ISO 180” – RODAC wall – air sampler portable single unit for Clean Room
It uses a simple Contact Plate. The air flow is 180 litres per minute.
1000 litres of air are aspirated in apprx. 6 minutes.
(q) “SAS Super ISO 100" – PETRI wall air sampler portable single unit for Clean Room
It uses a simple Petri dish. The air flow is 100 litres per minute
1000 litres of air are aspirated in 10 minutes
(r) “SAS Super ISO 180" – PETRI wall air sampler portable single unit for Clean Room
It uses a simple Petri dish. The air flow is 180 litres per minute
1000 litres of air are aspirated in appr. 6 minutes

Air samplers Twins model for Clean Room
(s) “DUO-SAS-360” – RODAC - air sampler with two aspirating heads portable single unit for Clean Room
It uses two simple Contact Plate. The air flow is 180+180 = 360 litres per minute.
1000 litres of air are aspirated in approx 3 minutes.
(t) “DUO-SAS-360” PETRI - air sampler with two aspirating heads portable single unit for Clean Room
It uses a simple Petri dish. The air flow is 180+180 = 360 litres per minute.
1000 litres of air are aspirated in approx 3 minutes.
(u) “DUO-SAS-360” – RODAC – vertical air sampler with two aspirating heads portable single unit for Clean Room
It uses two simple Contact Plate. The air flow is 180+180 = 360 litres per minute.
1000 litres of air are aspirated in approx 3 minutes.
(v) “DUO-SAS-360” PETRI – vertical air sampler with two aspirating heads portable single unit for Clean Room
It uses two simple Petri dish. The air flow is 180+180 = 360 litres per minute.
1000 litres of air are aspirated in approx 3 minutes.

Air sampler for Isolator / Clean Room
(w) “SAS Isolator 100” – RODAC air sampler with stainless steel separated aspirating head for Clean Room
It uses a simple Contact Plate. The air flow is 100 litres per minute.
1000 litres of air are aspirated in 10 minutes.
(z) “SAS Isolator 180” – RODAC air sampler with stainless steel separated aspirating head for Clean Room
It uses a simple Contact Plate. The air flow is 180 litres per minute.
1000 litres of air are aspirated in approx 6 minutes.
(k) “SAS Isolator 100” – PETRI air sampler with stainless steel separated aspirating head for Clean Room
It uses a simple Petri dish. The air flow is 100 litres per minute.
1000 litres of air are aspirated in 10 minutes.
(j) “SAS Isolator 180” – PETRI air sampler with stainless steel separated aspirating head for Clean Room
It uses a simple Petri dish. The air flow is 180 litres per minute.
1000 litres of air are aspirated in approx 6 minutes.

Multi air samplers with command single unit for Clean Room
(i) “SAS Super 100 Multi Isolator 100" – RODAC air sampler fixed unit for Clean Room
It uses a simple Contact Plate. The air flow is 100 litres per minute.
1000 litres of air are aspirated in 10 minutes.
(ii) “SAS Super 180 Multi Isolator 180" – RODAC air sampler fixed unit for Clean Room
It uses a simple Contact Plate. The air flow is 180 litres per minute.
1000 litres of air are aspirated in approx 6 minutes.
(iii) “SAS Super 100 Multi Isolator 100" – PETRI air sampler fixed unit for Clean Room
It uses a simple Petri dish. The air flow is 100 litres per minute.
1000 litres of air are aspirated in 10 minutes.
(iv) “SAS Super 180 Multi Isolator 180" – PETRI air sampler fixed unit for Clean Room
It uses a simple Petri dish. The air flow is 180 litres per minute.
1000 litres of air are aspirated in approx 6 minutes.

Air sampler net-work for Clean Room
(v) “SAS Super ISO NET-WORK 100” RODAC - NETWORK fixed unit air sampler controlled by external P.C. for Clean Room
It uses a simple Contact Plate. The air flow is 100 litres per minute.
1000 litres of air are aspirated in 10 minutes.
(vi) “SAS Super ISO NET-WORK 180” RODAC - NETWORK fixed unit air sampler controlled by external P.C. for Clean Room
It uses a simple Contact Plate. The air flow is 180 litres per minute.
1000 litres of air are aspirated in approx 6 minutes.
(vii) “SAS Super ISO NET-WORK 100” PETRI - NETWORK fixed unit air sampler controlled by external P.C. for Clean Room
It uses a simple Petri dish. The air flow is 100 litres per minute.
1000 litres of air are aspirated in 10 minutes.
(viii) “SAS Super ISO NET-WORK 180” PETRI - NETWORK fixed unit air sampler controlled by external P.C. for Clean Room
It uses a simple Petri dish. The air flow is 180 litres per minute.
1000 litres of air are aspirated in approx 6 minutes.

Air sampler for compressed air / gas in Clean Room
(ix) “Pinocchio Super II" – RODAC – air sampler for compressed air/gas in Clean Room
(x) “Pinocchio Super II" – RODAC – air sampler for compressed air/gas in Clean Room (with calibration certificate)
(xi) “Pinocchio Super II" – PETRI – air sampler for compressed air/gas in Clean Room
(xii) “Pinocchio Super II" – PETRI – air sampler for compressed air/gas in Clean Room (with calibration certificate)

Quality Control System for air samplers in Clean Room
(xiii) “Pyramid” air flow meter for SAS in Clean Room
For monitoring the performances of air samplers in Clean Room

Accessories for Clean Room Air Samplers
(xiv) “Clean Tripod” stainless steel floor tripod in Clean Room
(xv) “SAS Holder” stainless steel wall/surface/cart holder in Clean Room
(xvi) “Stand up holder” stainless steel vertical stand for SAS in Clean Room
(xvii) “Plate carrier” stainless steel RODAC plate carrier in Clean Room
(xviii) “Plate carrier” stainless steel PETRI plate carrier in Clean Room

Sterile, tripled packed Contact Plate with media for Clean Room
(xix) Agar Contact blister TSA for total count in Clean Room
(xx) Agar Contact blister TSA with agents for neutralizing disinfectants for total count in Clean Room
(xxi) Agar Contact blister SDA for total count of moulds and yeasts in Clean Room
(xxii) Agar Contact blister SDA with agents for neutralizing disinfectants for total count of moulds and yeasts in Clean Room

Question:
Which is the method principle of the “SAS” Surface Air System microbiological air samplers?

Answer:
-Introduction
The purpose of the use of “SAS” method is the count of the micro-organisms present in the air of an environment to evaluate the microbiological conditions according to national or international standards and/or Guidelines for safety / health reasons.
-Sampling
A known volume of air is aspirated inside the aspirating chamber of the sampler. The micro-organisms are captured by impact on the agar surface of a plate (Contact Plate or Petri dish).
Different media are used for different micro-organisms (e.g.: Sabouraud Dextrose Agar (SDA) for yeast and moulds, Tryptic Soy Agar (TSA) for total bacterial count).
-Microbial population growing
The Contact Plate or Petri dish is incubated at different temperature for different time according to specific accepted national / international standards (e.g. 32°C; 37°C, etc. for 24, 48, 72 hours, etc.).
-Colony counting
At the end of incubation time, the colonies are visible on the agar surface of the plate and the Colony Forming Units (CFU) are counted.
-Count standardization
The number of the CFU of a plate is referred to CFU/ 1000 liters (1 cubic metre) of air.
-Interpretation
The number of CFU should be considered in terms of limit (e.g.: Yes/No) or trend (e.g.: line going up or going down) on a graphic that considers the previous results or specifications.

Question:
Where do you find useful information for the microbiological sampling of air, hands, surfaces (application notes, expert, methods, references, legislation, etc.)?

Answer:
Visit the site “The SAS Family”.

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