Microbial Impaction Sampler for Clean Room Gas Monitoring TEST AIR INSTRUCTION MANUAL 1
INSTRUCTION MANUAL READ THIS HANDBOOK CAREFULLY 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 4 bar to the inlet.. INSTALLATION GENERAL CAUTION Be aware that pressure applied to the inlet is lower than 4 bar. CAUTION. 2
SUMMARY 1. Introduction.. pg. 5 2. Characteristics. pg. 5 3. How does Test Air work.........pg. 6 4. Components... pg. 7 5. Installation.........pg. 9 6. Operations...... pg. 10 7. Servicing..... pg. 11 8. Spare parts...... pg. 12 9. Scheme........ pg. 12 10. Standard Operating Procedure (SOP)....... pg. 13. 3
SHORT INSTRUCTIONS Method of use - A) The contact plate with medium is inserted in the housing. B) Test Air 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. 4
1. INTRODUCTION The Test Air 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 Test Air. An official validation of the Test Air air sampler is required as the event of an inspection. The flow meter of Test Air should be calibrated by an official agency at regular intervals (usually every year). Official validation of the flow meter may also be performed by Galleon s customer support service. 2. CHARACTERISTIC Size 444 X 300 X 290h mm Weight Kg. 5 Construction Stainless steel Anodized aluminium Air flow meter Max temperature 50/400 SCFH 10 C - 40 C room temperature Power supply Max altitude External temperature Max relative humidity Compressed air N/A N/A N/A Not material Max inlet pressure 4 bar 5
3. HOW DOES Test Air WORK Compressed air source should be connected to the Test Air 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.. 6
4. COMPONENTS Components of Test Air : FRONT PICTURE (a) Stainless steel base (b) Air flow meter (c ) Adjustment knob of the air flow meter (d) One Way Air Inlet Valve (d1) Air inlet valve connection for air flow adjustment (no involved sterility in this phase of sampling) - (d2) (1);(3) Air inlet valve connection for microbiological air test (involved sterility in this phase of sampling) - (e) (2);(4) Triangular S/S metal plate (f) Double O-rings connection between the Test Air and the Test Air Funnel (g) Test Air funnel head Petri Version (h) Collar - Petri Version (i) Contact Plate housing (j) Test Air funnel support (k) Handle (l) SAS Super 100 support (optional) (m) Air flow meter outlet (n) Tubing/Elbow connection between metal block and Test Air funnel (o) Test Air Funnel Connection 7
REAR PICTURE image 8
5. INSTALLATION The compactness of Test Air 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 air flow meter is 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 inlet gasing source to (D). c. Fix the air flow meter connection (B) in the front to the backside elbow with a triangle SS Plate d. Fix the funnel support (J) on the base e. Insert the double O-ring connection (F) into the funnel f. Position the funnel (H) on its support and fix it to the air outlet g. Screw the Contact Plate housing (I) to the funnel head air flow meter (B) is not autoclavable 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 90MM Petri dish with sterile medium in the Test Air funnel housing and screw it to the conical head. Do not connect to the Test Air. 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 Test Air funnel to the Test Air. 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 Petri dish to the laboratory for incubation. 6.7 The Test Air 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. CALIBRATION 6.9 The air flow meter may be officially calibrated each year.. 10
CONVERSION TABLE FROM SCFH TO litre/min The readings of the air flow meter should be transformed in litres per minute. Follow the reported table. SCFH litri/min 40 18,88 45 21,24 50 23,6 55 25,96 60 28,32 65 30,68 70 75 33,04 35,4 80 37,76 85 40,12 90 42,48 95 44,84 100 47,2 105 49,56 110 51,92 115 54,28 120 56,64 125 59 130 135 61,36 63,72 140 66,08 145 68,44 150 70,8 155 73,16 160 75,52 165 77,88 170 80,24 175 82,6 180 84,96 185 87,32 190 195 89,68 92,04 200 94,4 205 96,76 210 99,12 215 101,84 220 103,84 SCFH litri/min 225 106,84 230 108,56 235 110,92 240 113,28 245 115,64 250 118 255 260 120,36 122,72 265 125,08 270 127,44 275 129,8 280 132,16 285 134,52 290 136,88 295 139,24 300 141,6 305 143,96 310 146,32 315 320 148,68 151,04 325 153,4 330 155,76 335 158,12 340 160,48 345 162,84 350 165,2 355 167,56 360 169,92 365 172,28 370 174,64 375 380 177 179,36 385 181,72 390 184,08 395 186,44 400 188,8 7. SERVICING For a correct maintenance of the instrument just follow these sample steps: the instrument should be cleaned regularly and stored to avoid dust accumulation. 11
8. SPARE PARTS Components of Test Air : (a) Stainless steel base (b) Air flow meter (the figures are in feet) (c ) Adjustment knob of the air flow meter (d) One way air inlet connection (d1) Air inlet valve connection for air flow adjustment (no involved sterility in this phase of (d2) sampling) Air inlet valve connection for microbiological air test (involved sterility in this phase of (e) sampling) Triangular S/S metal plate (f) (g) (j) (m) (n) (o) (p) (q) (r) Double O-rings connection between the Test Air and the Test Air funnel Test Air funnel head Petri Version Collar Petri Version Contact Plate housing Test Air funnel support Handle SAS Super 100 support (optional) Air flow meter outlet Tubing/Elbow connection between metal block and Test Air funnel air flow meter (b) is non autoclavable 9. SCHEME 12
10. STANDARD OPERATING PROCEDURE GAS 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, STANDARDS - Test Air instruction Manual RESPONSIBILITY - Production Manager or Laboratory Manager MATERIAL Equipment: - Test Air Petri (1651) microbiological impaction sampler using Petri dish Components of Test Air : (a) Stainless steel base code: 251-35 (b) Air flow meter (the figures are in feet) code: 251-38 (c ) Adjustment knob of the air flow meter code: 251-39 (d) One way air inlet connection code: 251-43 (d1) Air inlet valve connection for air flow adjustment code: 251-44 (d2) Air inlet valve connection for microbiological air test code: 251-45 (e) Triangular S/S metal plate code: 251-49 (f) Double O-rings connection between the Test Air and the Test Air funnel code: 251-60 (g) Test Air funnel head code: 251-61 Petri Version (j) Collar code: 251-62 Petri Version (m) Contact Plate housing code: 251-63 (n) Test Air funnel support code: 251-64 (o) Handle code: 251-66 (p) SAS Super 100 support (optional) code: 251-71 (q) Air flow meter outlet code: 251-72 (r) Tubing/Elbow connection between metal block and Test Air funnel code: 251-73. 13
All the connections are Quick Disconnect - Connection to gas outlet Test Air 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 Test Air 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 air flow meter is 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. Insert an identified Petri dish with sterile medium in the Test Air funnel housing and screw it to the conical head. Do not connect to the Test Air. 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 Test Air funnel to the Test Air. 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 Test Air 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. 14
GLOSSARY TERMS 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 Bacterial spore rate A resistance of airflow body is expressed produced in by terms a vegetative of volume bacterial per unit cell.these time spores may be resistant to heat, U.V., desiccation and may remain dormant for Bactericide extended A substance period or formulation of time 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 microorganisms A measure of the number of micro-organisms on or within products and Bioburden inanimate objects. A common synonym is microcount C.F.U. Colony Forming Unit An individual ore an aggregate of many microbial cells Challenge aerosol which, The concentration when cultivated of an on aerosol solid media, (e.g.: number will develop of particles into a single per unit visual volume) used Contaminant o Any challenge unwanted a system substance under present specified in or conditions 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- Flora organisms The types of microbiological organisms found in an environment Fungi A nonphotosyntetic micro-organisms possessing cell walls ad usually growing Impaction as Physical a mass contact of branching of particles interlacing with other filaments surfaces known as mycelia Micro-organism Name that include bacteria, yeasts, moulds, viruses Monitoring The routine determination of airborne particle concentration as well as other Particle relevant An object parameters 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 Sampling with A process an antimicrobial consisting substance 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 Sporicide extended A substance period or formulation of time capable of destroying bacterial spore Sterilisation A physical or chemical process that completely destroys or eliminates all forms Total Bacterial Count of The microbial total number life of micro-organisms present in a substance Validation Establishment, by means of a specified testing program, that a system under test Viable particle is A particle capable capable of performing of reproduction as intended ; 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. 15
WARRANTY WARRANTY CONDITIONS Galleon Instru-Tech warrants this product to be free of defects in materials and functionality The repairs will be effected by Galleon Instru-Tech or by authorized dealers as follows: - Faulty components free replacement The labour is always at customer's expense - The equipment will be sent at buyer's expenses and risk and the return will be ex-works - This warranty does not apply to damages resulting from tamperings,abnormal use and installation and does not cover transport damages - Galleon Instru-Tech shall not be liable for any commercial damages, whether incidental, consequential or otherwise derived from the use of instruments ATTENTION TO OUR NEW CUSTOMER As a user of our equipment you are covered for a 12 months guarantee for all spare parts as a result of mechanical failure of the machine during normal use. In order to provide you with first class service, it is essential for us to know all your references and which equipment you have. We kindly ask you therefore to fill in the attached guarantee and return the card to us by first class mail.