Trace Analytics, LLC • 800-247-1024 • 512-263-0000 i [email protected] • www.AirCheckLab.com Thank you for selecting the Team of Experts at Trace Analytics, LLC for your compressed air and pure gas analyses. We appreciate your business and look forward to a long lasting relationship with you. Please do not hesitate to contact us with your air related questions. Phone: 512-263-0000 Toll-Free US & Canada: 800-247-1024 Fax: 512-263-0002 Customer Service E-mail: [email protected]After Hours Emergency: [email protected]Website Address: www.AirCheckLab.com Return KPSII to : Trace Analytics, LLC 15768 Hamilton Pool Rd. Austin, TX 78738 Submit Microbial Samples: Use UPS Next Day Pre-Addressed Labels to 3rd Party Accredited Laboratory Saturday Deliveries Must be Pre-scheduled Trace Hours: 8-5, CST, Mon - Thurs 8-3, CST, Friday Saturday Deliveries Must be Pre-scheduled KPSII is the property of Trace Analytics, LLC Pinocchio Super II Microbial Impaction Sampler for Compressed Air & Gas Monitoring the Document Name: PSII02013V1
Thank you for selecting the Team of Experts at Trace Analytics, LLC for your compressed air and pure gas analyses. We appreciate your business and look forward to a long lasting relationship with you. Please do not hesitate to contact us with your air related questions.
Phone: 512-263-0000 Toll-Free US & Canada: 800-247-1024 Fax: 512-263-0002
How to Contact Us ....................................................................................................................................... i
Notes before Sampling .............................................................................................................................. 1-1Sampling Protocol ....................................................................................................................................... 1-2Chain of Custody .......................................................................................................................................... 1-3Pinocchio Super II Instruction Manual ............................................................................................... 1-4Calibration Documentation ..................................................................................................................... 1-17Glossary of Terms ......................................................................................................................................... 1-18
AirCheckNotes, issued periodically, are available for viewing and download from our Helpful Technical Info section on our website: www.AirCheckLab.com
About Trace Analytics, LLCAccreditation Documentation – current Scope of Accreditation and Certification documents Example Report – sample AirCheckReport and certificateValidation Report – available by requestLaboratory SOPs – available by requestTrace Analytics Overview – company info, lab facilities, analytical techniques and QC procedures
About the AirCheckKitKit Sampling Instructions – included with every AirCheckKit soldBlank Data Sheet – form that must accompany every sample submitted for analysis
1. Rental of the Pinocchio Super II (KPSII) Microbial Sampler The KPSII is available for RENTAL ONLY. Refer to your purchase order for the number of days
rented. Rental period includes transportation days to and from your location. The KPSII must be returned via enclosed UPS Next Day Return Label. Shipping charges apply.
The KPSII is the property of Trace Analytics, LLC. Frequently, the sampler is pre-scheduled for delivery to another client. Failure to return
sampler on date scheduled is subject to additional penalty fees. If additional days are required, contact Trace for availability. A modification to the original Purchase Order will be required.
2. Sample Submission and Chain of Custody It is essential to ensure sample integrity from initial collection to final reporting. This includes
the ability to trace possession of the sample from collection point to receipt at the laboratory. A chain of custody (COC) form must accompany all samples submitted to the laboratory. This form contains fields for reporting, billing, sample identification and analyses requested.
3. Sample Containers and Delivery to the Laboratory All individual sample containers must be properly labeled with the sample ID exactly as written
on the chain of custody to prevent misidentification. Labeling is most legible when done with a fine tipped permanent marker. Write the sample ID only on the underside of the agar plate (the side which contains the media). Plates should be sealed with parafilm or tape to prevent cross contamination. After a sample has been taken, seal and hold the top and bottom by stretching a piece of 3/4 to 1” parafilm or tape, all the way around the circumference of the agar plate. Do not write on the parafilm or tape as this will be removed at the laboratory.
Put plates back into plastic bags in which they were originally packed. Bags of plates should be wrapped in bubble wrap or other packing material, such as styrofoam peanuts or heavy paper. It is especially important to pad the bottom and corners of the shipping box.
Ship box with cold packs. Do not ship samples or PSII over a weekend. If samples must be shipped for Saturday analysis: This MUST be scheduled in advance to coordinate availability of personnel with 3rd party micro laboratory. Contact Trace at least 1 day in advance.
4. Shipping Instructions Return the KPSII via UPS Next Day (billable return tag included) to Trace Analytics, LLC • 15768
Hamilton Pool Road • Austin TX 78738. Do not ship over the weekend. Return Samples to the laboratory as soon as possible after collection because some tests may
have very short hold times. Overnight delivery in climate-controlled containers is required. Use the FedEx Next Day (billable shipping tag included). The samples are being shipped to a 3rd party, accredited microbial testing laboratory. DO NOT send samples to Trace Analytics, LLC.
This protocol is suggested to assist the on-site investigator in developing an overall sampling strategy. Trace Analytics does not assume responsibility for selection of the appropriate sampling protocol. These decisions must be made by the on-site investigator. Improper aseptic sampling techniques can hinder the success of even the most well planned monitoring program. Employees with limited or no aseptic training can unknowingly contaminate samples and compromise the validity of test results. This can trigger retests, production delays, and even lead to product recalls. Sampling should be done by a trained environmental health professional with experience in sampling for microorganisms; therefore, this protocol should not be considered a complete sampling guide.
INSTRUCTIONS FOR USING PINOCCHIO SAMPLER AND RECORDING DATA 1. At the job location, record the Sample description and the Sample number on the Sample
Submission Form/Chain of Custody Sheet (see example on next page, extra copies provided). 2. Before sampling at each sampling site, thoroughly wash hands with soap and water, don clean
gown and sterile, disposable gloves. Gloves and gown should be worn and changed as often as necessary to minimize cross-contamination. Do not touch mouth, nose, eyes, and face.
3. Clean the inlet gas valve and Pinocchio II funnel by wiping them both inside and outside with an alcohol sponge. If available, a product such as Spor-Klenz® Ready to Use Spray may be used. Reassemble and allow alcohol or Spor-Klenz to air dry for approximately 30-60 seconds; then load media for sampling. Do not touch agar surface with fingers. Be careful to use aseptic techniques.
4. Sanitize surfaces on which collection plates are laid before and after sampling to minimize the chances of cross-contamination.
3. Air should be collected at each sampling site following Pinocchio II sampling instructions, see following pages.
4. Reseal plates with parafilm strips or tape after exposure in the sampler. Put plates back into plastic bags in which they were originally packed. Pack plates with the exposed agar side up to prevent agar from falling out during shipment. DO NOT SHIP PLATES UPSIDE DOWN. It is essential that plates be shipped to the laboratory by overnight courier for morning delivery. It is necessary that the plates arrive at the laboratory and be incubated at appropriate temperatures before visible growth develops on them. For this reason, a return Next Day Airbill is provided.
5. Enclose a copy of the Sample Submission Form/Chain of Custody with the exposed sample plates being returned to the microbial laboratory, retain a copy for your records, and include a copy with the Pinocchio II. The Pinocchio II is returned to Trace Analytics. Billable shipping labels are provided for both shipments.
Trace Analytics, LLC uses a 3rd party, A2LA accredited laboratory for microbial analyses. Results will be e-mailed to Trace Analytics LLC, then forwarded to authorized contacts on file.
Complete shaded items only. Return original form with samples, send copy with PSII, keep copy.
Client Trace Analytics LLC Date Sampled: Report to Dick Smith Sampled by: Address 15768 Hamilton Pool Rd. Purchase Order #
SAFETY INSTRUCTIONS • Use the device just for the indicated purposes.• The Device must be correctly used according to manual instructions, before starting any operation.• Replace immediately electrical cable when damaged.• Use original spare parts and accessories for any replacement; • If this device is used with extremely high pressurized gas you must connect to the inlet a pressure reducer in
order to have a max of 60 psig (4 bar) to the inlet..
INSTALLATION GENERAL CAUTION
CAUTION
Be aware that pressure applied to the inlet is lower than 60 psig (4 bar).
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 2
SHORT INSTRUCTIONSMethod of use - A) The contact plate with medium is inserted in the housing. B) PINOCCHIO-SUPER II is connected to the compressed air output.C) The operator adjusts the air flow by the knob of the meter. D) the operator controls the volume of compressed air (or gas) by a timer (e.g. 10 minutes for 1000 litres of air). E) At the end the contact plate is transferred to incubator for CFU counting.
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 4
A Connect “Pinocchio Super” to the compressed gas output
B Plate Identification C Plate transfer to “Pinocchio Super” Housing
D Compressed gas tap opening
E Gas flow regulation (100 lts/min
F Plate recovery at the end of sampling time and incubation
1. INTRODUCTION The “Pinocchio Super II” microbiological gas sampler is a portable instrument for determining the level of existent microbiological contaminants in the compressed gas of an aseptic manufacturing operations.
Official control of “Pinocchio Super II”. An official validation of the “Pinocchio Super II” air sampler is required as the event of an inspection.The flow meter of “Pinocchio Super II” should be calibrated by an official agency at regular intervals (usually every year). Official validation of the flow meter may also be performed by PBI’s customer support service.
2. CHARACTERISTIC
Dimensioni / Size 400 X 210 X 250h mm Peso / Weight Kg. 5
Costruzione / Construction Acciaio inossidabile / Stainless steel Alluminio anodizzato / Anodized aluminium
Flussometro / Air flow meter 50/400 litri / liters Temperatura massima / Max temperature 10 °C - 40
°Ctemperatura ambiente / room temperature
Allacciamento elettrico / Power supply N/AMassima altitudine / Max altitude N/A
Temperatura esterna / External temperature N/AUmidità relativa massima / Max relative humidity Not material
Aria compressa / Compressed air Max inlet pressure 4 bar
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 5
3. HOW DOES “PINOCCHIO SUPER II” WORK Compressed air source should be connected to the “Pinocchio Super II” system. The flow meter is regulated at the correct volume (e.g.: 100 lts of air/minute for SAS Super 100): 1000 litres of air will impact in ten minutes the agar nutrient medium of a Contact Plate (or Petri dish).The Contact plate (or Petri dish) is then incubated and the CFU counted.
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 6
(a) Stainless steel base cod. 50494(b) Air flow meter (the figures are in feet) - (7) cod. 77633(c ) Adjustment knob of the air flow meter cod. 77633(d) Two ways air inlet connection cod. 77713(d1) Air inlet valve connection for air flow adjustment (no involved sterility in this phase of sampling) - (1);(3) cod. 77713(d2) Air inlet valve connection for microbiological air test (involved sterility in this phase of sampling) - (2);(4) cod. 77713(e) Triangular S/S metal plate cod. 50495(f) Pressure gauge - (6) cod. 50282(g) Double O-rings connection between the “Pinocchio Super II” and the “Pinocchio funnel” cod. 35084(h) “Pinocchio funnel head” Contact Version cod. 19239 (std) / 85362 (SS) Petri Version cod. 85476 (std) / 85477 (SS) (i) Collar - (8) Contact Version cod. 90050 Petri Version cod. 25884(l) Contact Plate housing cod. 90174(m) “Pinocchio funnel” support cod. 50496(n) Handle cod. 69606(o) SAS Super 100 support (optional) cod. 50506(p) Air flow meter outlet cod. 65042(q) Parallelepiped aluminium block cod. 50514(r) Tubing/Elbow connection between metal block and “Pinocchio” funnel cod. 65042(q) Pinocchio Funnel Connection – (5);(8)
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 7
5. INSTALLATION The compactness of “Pinocchio Super II” sampler provides the possibility to locate the sampling device where space is limited. The simple construction coupled with simple operation enable accurate reports about air – gas microbiology quality. The unit is completely dismantled for easy cleaning and autoclave sterilisation.The pressure gauge and the air flow meter are not autoclavable. Follow the schematic drawing for assembling.All connections are “quick disconnect”. Connect the unit to the desired point of sampling using a suitable sterile tubing. The inlet gas valve should be in a closed position.
ASSEMBLING a. Position the stainless steel base (A) in front of the operator b. Fix the central metal block on the s/s base in its fissure c. Fix the pressure gauge (F) on top of central block d. Fix the air inlet connection (D) on the back of the central block e. Fix the air outlet connection (E) on the top of the central block f. Fix the air flow meter connection (B) on the front of the central block g. Fix the funnel support (M) on the base h. Insert the “double O-ring” connection (G) into the funnel i. Position the funnel (H) on its support and fix it to the air outlet l. Screw the Contact Plate housing (L) to the funnel head (I)
air flow meter (B) and pressure gauge (F) are not autoclavable
The Air Inlet Connection Valve (d) has an arrow on the sides which indicates the direction of the air flow going towards the quick connection.
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 9
6. OPERATIONS PREPARATION 6.1 Connect the unit to the desired point of sampling using a suitable sterile tubing. The inlet gas valve should be in a closed position. 6.2 Insert an identified Contact plate (RODAC) or Petri dish with sterile medium in the “Pinocchio funnel” housing and screw it to the conical head. Do not connect to the “Pinocchio Super II”.
AIR FLOW ADJUSTMENT 6.3. Open the line of compressed air or gas line. Open the (D+D1) valve and adjust the air flow on the flow meter to 100 lts / minute (210 SCFH). The purpose of this operation is to obtain a known volume of air, without contaminating the sampling circuit.
COMPRESSED GAS SAMPLING 6.4. Connect the Pinocchio funnel to the Pinocchio Super II. Close the (D1) valve and open the (D2) valve and start the count down. 6.5 Close the gas valve after 10 minutes (1000 litres of air are collected). 6.6 Unscrew the head and transfer the Contact plate (RODAC) or Petri dish to the laboratory for incubation. 6.7 The “Pinocchio Super II” is ready for a new test. 6.8 Count the Colony Forming Units in the plate at the end of incubation time and report the results as CFU/1000 litres of gas/compressed air.
SAMPLING DATA RECORDING 6.9 If the sampling data should be recorded, replace the plate housing with the SAS Super air sampler and start from point 4 to 6.The time will be regulated by the sampler timer.
CALIBRATION 6.10 The air flow meter may be officially calibrated each year.
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 10
8. SPARE PARTSComponents of “Pinocchio Super II”: (a) Stainless steel base cod. 50494(b) Air flow meter (the figures are in feet) cod. 77633(c ) Adjustment knob of the air flow meter cod. 77633(d) Two ways air inlet connection cod. 77713(d1) Air inlet valve connection for air flow adjustment (no involved sterility in this phase of sampling) cod. 77713(d2) Air inlet valve connection for microbiological air test (involved sterility in this phase of sampling) cod. 77713(e) Triangular S/S metal plate cod. 50495(f) Pressure gauge cod. 50282(g) Double O-rings connection between the “Pinocchio Super II” and the “Pinocchio funnel” cod. 35084(h) “Pinocchio funnel head” Contact Version cod. 19239 (std) / 85362 (SS) Petri Version cod. 85476 (std) / 85477 (SS) (i) Collar Contact Version cod. 90050 Petri Version cod. 25884(l) Contact Plate housing cod. 90174(m) “Pinocchio funnel” support cod. 50496(n) Handle cod. 69606(o) SAS Super 100 support (optional) cod. 50506(p) Air flow meter outlet cod. 65042(q) Parallelepiped aluminium block cod. 50514(r) Tubing/Elbow connection between metal block and “Pinocchio” funnel cod. 65042
air flow meter (b) and pressure gauge (f) are not autoclavable
9. SCHEME
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 12
10. STANDARD OPERATING PROCEDUREGAS AND COMPRESSED AIR MICROBIOLOGICAL SAMPLING: Standard Operatine Procedure
INTRODUCTION - The following SOP will assist a laboratory to prepare its own procedure.
STANDARD OPERATING PROCEDURE OBJECT - Quantitative micro-organism collection in compressed air and gas lines
OBJECTIVE - Testing the microbiological quality of compressed air and gas to avoid contamination inside controlled environments
TERMINOLOGY - Air flow meter, Colony Forming Unit, CFU, Clean Room, Contact Plate, Impaction, Litres per minute, Microbiological medium, Petri dish, Pressure Gauge, RODAC
STANDARDS - “PINOCCHIO SUPER II” instruction Manual
RESPONSIBILITY - Production Manager or Laboratory Manager
MATERIAL Equipment: -“Pinocchio Super II Contact” (Cat.n. 39089) microbiological impaction sampler using ContactPlate -“Pinocchio Super II Petri (Cat.n. 35026) microbiological impaction sampler using Petri dish Components of “Pinocchio Super II”: (a) Stainless steel base cod. 50494(b) Air flow meter (the figures are in feet) cod. 77633(c ) Adjustment knob of the air flow meter cod. 77633(d) Two ways air inlet connection cod. 77633(d1) Air inlet valve connection for air flow adjustment (no involved sterility in this phase of sampling) cod. 77633(d2) Air inlet valve connection for microbiological air test (involved sterility in this phase of sampling) cod. 77633(e) Triangular S/S metal plate cod. 50495(f) Pressure gauge cod. 50282(g) Double O-rings connection between the “Pinocchio Super II” and the “Pinocchio funnel” cod. 35084(h) “Pinocchio funnel head” Contact Version cod. 19239 (std) / 85362 (SS) Petri Version cod. 85476 (std) / 85477 (SS) (i) Collar Contact Version cod. 90050 Petri Version cod. 25884(l) Contact Plate housing cod. 90170(m) “Pinocchio funnel” support cod. 50496(n) Handle cod. 69606(o) SAS Super 100 support (optional) cod. 50506(p) Air flow meter outlet cod. 65042(q) Parallelepiped aluminium block cod. 50514(r) Tubing/Elbow connection between metal block and “Pinocchio” funnel cod. 65042
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 13
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 14
All the connections are “Quick Disconnect”
- Connection to gas outlet “Pinocchio Super II” may be used with or without SAS Super air sampler.
Consumables: - Sterile Contact plates (RODAC) or standard 90 mm Petri dish with TSA medium
PROTOCOL The compactness of “Pinocchio Super II” sampler provides the possibility to locate the sampling device where space is limited.The simple construction coupled with simple operation enable accurate reports about air – gas microbiology quality. The unit is completely dismantled for easy cleaning and autoclave sterilisation.The pressure gauge and the air flow meter are not autoclavable. Follow the schematic drawing for assembling. All connections are “quick disconnet”. Connect the unit to the desired point of sampling using a suitable sterile tubing.The inlet gas valve should be in a closed position. Insert an identified Contact plate (RODAC) or Petri dish with sterile medium in the “Pinocchio funnel” housing and screw it to the conical head. Do not connect to the “Pinocchio Super II”. Open the line of compressed air or gas line. Open (D) and (D1) valve and adjust the air flow on the flow meter to 100 lts / minute (210 SCFH). The purpose of this operation is to obtain a known volume of air. Connect the Pinocchio funnel to the Pinocchio Super II. Close the (D1) valve and open the (D2) valve and start the count down. Close the gas valve after 10 minutes (1000 litres of air are collected). Unscrew the head and transfer the Contact plate (RODAC) or Petri dish to the laboratory for incubation. The “Pinocchio Super II” is ready for a new test. Count the Colony Forming Units in the plate at the end of incubation time and report the results as CFU/1000 litres of gas/compressed air. If the sampling data should be recorded, replace the plate housing with the SAS Super air sampler. The time will be regulated by the sampler timer. The air flow meter may be officially calibrated each year.
A note about Blind / Control SamplesISO 8573-7 Sampling procedure includes two blind or control samples, one before the actual sample exposed to compressed air and one after. The purpose of the blind sample is to identify if there are any environmental or handling issues that may affect test results. Take an unused Contact plate, insert it into the “Pinocchio funnel” housing and screw it into the conical head. Attach the Pinocchio funnel to the Pinocchio Super II. Wait for 30 seconds, remove the Pinocchio funnel, and remove the contact plate from the funnel. Immediately place lid onto contact plate, and record ID# and ID description onto Sample Submission Form/Chain of Custody.
A note about Handling of Contact PlatesThe lid should be removed only after the plate has been placed into the funnel to avoid undue exposure of the lid and agar filled plate to environmental conditions.The lid of the contact plate should be placed face down onto a clean, sanitized area or sterile bag when not on the plate.
International pbi S.p.A. "Pinocchio Super II” Instructions Manual Rev. 6 15
GLOSSARYTERMS DEFINITIONS
Airborne particles Particles suspended in moving or stationary air Airflow Movement of air in a given direction respect to a specified reference plane.The
rate of airflow is expressed in terms of volume per unit time Bacterial spore A resistance body produced by a vegetative bacterial cell.These spores may be
resistant to heat, U.V., desiccation and may remain dormant for extended period of time
Bactericide A substance or formulation capable of destroying bacteria Bacteriostat A compound or formulation that retards or prevent the growt of bacteria Bioaerosol gaseous suspension of fine solids or liquid particles carrying micro-organisms Bioburden A measure of the number of micro-organisms on or within products and
inanimate objects. A common synonym is microcount C.F.U. Colony Forming Unit – An individual ore an aggregate of many microbial cells
which, when cultivated on solid media, will develop into a single visual colony Challenge aerosol The concentration of an aerosol (e.g.: number of particles per unit volume) used
o challenge a system under specified conditions Contaminant Any unwanted substance present in or on a material or any surface Cyclone A system of rotating air spinning inward to a low pressure centre
counterclockwise Decontamination The removal of contaminant present in or on a material Disinfectant An agent, chemical or physical, designed to reduce the population on micro-
organisms Flora The types of microbiological organisms found in an environment Fungi A nonphotosyntetic micro-organisms possessing cell walls ad usually growing
as a mass of branching interlacing filaments known as mycelia Impaction Physical contact of particles with other surfaces Micro-organism Name that include bacteria, yeasts, moulds, viruses Monitoring The routine determination of airborne particle concentration as well as other
relevant parameters Particle An object that is solid, liquid or both usually between 1 nanometer and 1
millimeter in size Pathogen A micro-organisms capable of causing disease Residual activity Residue which may or may not be active that remain on surfaces after treatment
with an antimicrobial substance Sampling A process consisting of the withdrawal or isolation of a fractional part of a
whole
Spore A resistance body produced by a vegetative bacterial cell.These spores may be resistant to heat, U.V., desiccation and may remain dormant for extended period of time
Sporicide A substance or formulation capable of destroying bacterial spore Sterilisation A physical or chemical process that completely destroys or eliminates all forms
of microbial life Total Bacterial Count The total number of micro-organisms present in a substance Validation Establishment, by means of a specified testing program, that a system under test
is capable of performing as intended Viable particle A particle capable of reproduction ; a living organism Virus An obligate intracellular parasite, typically in the size range of 0,01 to 0,1 um,
that can infect and cause diseases in man, animals and insects
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