The key difference between laminar flow hoods and reverse laminar flow hoods is that the former protects items on the work surface while the latter protects operators. Spams/ Promotional links are not allowed and shall be deleted upon review. The line must operate in a clean room grade B or higher. Annexure V Pressure Differential, Noise and Illumination test CA License # A-588676-HAZ / DIR Contractor Registration #1000009744 Laminar Flow units are used to blow filtered air above areas requiring a sterile environment. 1 Laminar air flow has two filters i.e. 5.2.2 Clean the filters if the differential pressure across the filter exceed beyond the specified limit or as per the scheduled whichever is earlier. LAF: Laminar air flow Air velocity measured at 4 corners of the LAF as shown below and recording shall be done at V1, V2, V3 and V4 Calculate the average velocity. 5.4.2 Switch off the RLAF and isolate the power supply. 4.9 Noise and Illumination Test: This test shall be done to demonstrate Noise level and lightillumination of the equipment. MB : Microbiology very thankfuly for your comments. 4.7.2 Particle size used in this test shall be same as that used for the determination of cleanliness class. 4.4.6 Calculation of air flow supply 4.7.6 The time noted at which the particulate count regains the clean room specification. The reading of magnehelic gauge across the HEPA filter should be between 7 - 15 mm of Hg and across Pre-Filter . LAF - Laminar Air Flow Aseptic pharmaceutical . Ensure that the blower sucks the smoke through the return air filter. And third we have to direct the water into a laminar flow. This article will cover: Regulators such as the FDA in the United States or Health Canada ensure the quality of drug products. At rest, the number of particles allowed for each cubic meter is 352,000, while the number is 3,520, 000 in operation. can we have the specimen for Airflow patter test certificate. The blood flowing in our veins undergoes laminar flow. How many types of HEPA filters are there? These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. Necessary cookies are absolutely essential for the website to function properly. Reverse Laminar Air Flow is a purifying apparatus fitted with a high-efficiency HEPA filter to ensure maximum protection from airborne contaminants produced at the time of powder handling operations such as charging, sampling, and dispensing. 4.6.2 Check that following tests are passing before starting airborne particle count: 4.6.3 Particle count shall be checked at 3 locations per filter for RLAF and LAF and 1 location per filterfor Dynamic Pass Box at the height of the work activity. with www.yourflowergirl.com For the love of Roses.. What a great idea, A Food Basket Send a fruit and flower combo.. Other Funeral Gift Ideas-Florist In Gainesville GA., An extremely great set up for the loss of a loved one, fruit and flowers combo sent any time from a Florist In Gainesville Ga., . This cookie is set by GDPR Cookie Consent plugin. 5.2.4 Put FILTER CLEANING UNDER PROGRESS Tag on the Panel. Selecting and Using an Air Filter. Majorly used for mixed airflow stream to control the hazardous emission of dust powder during dispensing or sampling process. difference between laf and rlaf in pharma - travisag.com At rest, the Grade B cleanroom needs to meet a maximum of 3,520 particles (0.5 m) per cubic meter. 5.2.14 Check & ensure the filter is cleaned & look for the damages visually. 4.5 HEPA filter pressure difference test: Why does ulnar nerve injury causes claw hand? 6.2 Filter Cleaning schedule of process equipment Annexure -2 4.8.1 This test shall be done to demonstrate Laminar pattern of the air supplied. RLAF and LAF Diff - Pharmaguideline Forum Preparation of components and most products should be done at least in a Grade D cleanroom. 5.5.11 Filter cleaning can be done with in the period of one week under following conditions: 5.3 Cleaning Of Process Equipments APU Filters (FBD And Coating ) By itself, air cleaning or filtration is not enough to protect people from COVID-19. 4.3.9 Scanning shall be performed over the entire downstream face of each filter, the perimeter of each filter, the seal between the filter frame and the grid structure. 5.18 Store person shall weigh the material under RLAF cabinet and shall open the container under RLAF in the safe working zone. Comments shall be published after review. As these units discharge air towards user, they provide no personal protection but product protection from room contaminants. 5.3.6 Filter cleaning can be done with in the period of one week under following conditions: 5.4.7 Remove the filters from polythene bags and place the entire filter at the filter cleaning station for cleaning Purpose. Objective: Procedure. But opting out of some of these cookies may affect your browsing experience. I am currently continuing at SunAgri as an R&D engineer. 7.2 Controlled copies Engineering Department, cleaning and preventive maintenance of LAF and RLAF, sop for replacement of water system filters, cleaning and preventive maintenance of insectocutor, sop for operation of preventive maintenance, sop for material receiving and consumption record, sop for Preventive maintenance of bottle washing machine, sop for Replacement of Battery of Electronic Devices, sop for Preparation of R.O. Editable Pharmaceutical Documents in MS-Word Format. . 7.0 Distribution 5.2.3 Switch off the AHU and isolate the power supply. 5.2.1 Ensure that no production activities are being carried out in respective area for which filter cleaning is scheduled. Copyright Notice: This Article/SOP/Compilation/Published Content is protected by Indian & International Copyright Laws. LAF is short form of laminar air flow. However, you may visit "Cookie Settings" to provide a controlled consent. RLAF- 1. difference between laf and rlaf in pharma. What is difference between LAF and RLAF? - KOOLOADER.COM Dispensing booth is a kind of partial purifying equipment for filling, refilling, weighing and sampling of raw material and compounds. And why 15 minutes? This ensures to draw powder aerosols away from the operator and the operating environment protecting products. L&L : Liquid and Lozenges The line must operate in a clean room grade B or higher. Discard the used polythene bag. This type of air filter can theoretically remove at least 99.97% of dust, pollen, mold, bacteria, and any airborne particles with a size of 0.3 microns (m). Air velocity at each filter =S Air velocity at different locations of filter/Number of locations per filter Reverse laminar flow cabinets use the same streamlined, constant airflow to provide particulate direction. 5.4.9 Repeat the procedure as mentioned in 5.2.7 to 5.2.17. Weblink https://pharmastate.com/ 5 Filter Cleaning of Laminar Air Flow Monthly What is the differences between LAF & RLAF? LAF Laminar Air Flow Aseptic pharmaceutical manufacturing requires the production area to be free from microbiological and particle contamination. What is manufacturing process in pharmaceutical industry? In operation, the number of permitted airborne particles increases to 352,000 (0.5 m) for each cubic meter of air. {getWidget} $results={5} $label={recent} $type={list1}, Pharmaceutical Interview Questions and Answers, Different Types of Deviations in Pharmaceutical Industry, Pharmaceutical QA Interview Questions and Answers, Measurement of Weight Variation as per USP. Holiday 5.5.7 Remove the filters from polythene bags and place the entire filter at the filter cleaning station for cleaning Purpose. Then clean properly the working chamber from ceiling, followed by side glass and then the platform of the chamber with 70% IPA. The Grade B room of your GMP facility must be equipped with a particle monitoring system including an alarm if limits are exceeded. Can Helicobacter pylori be caused by stress? Editable Pharmaceutical Documents in MS-Word Format. 4.4.3 The uniformity of velocity shall be measured at approximately 150 mm to 300mm from the filterface. DPI : Dry Powder Injection Purpose: To lay down a procedure for Operation and Cleaning of Reverse Laminar Air Flow (RLAF) and RLAF Filter. SAT: Site Acceptance Test 6.0 DEFINITION: Equipment Qualification Master Plan (EQMP): A summary document prepared as part of project planning that describes overall philosophies, approaches, and objectives to all aspects of the qualification. 4.0 Abbreviations and Definitions . To lay down a procedure for performance qualification of LAF, RLAF and dynamic pass box. 3.2 Engineering Manager shall be responsible for the implementation of this SOP. 4 Filter Cleaning of Reverse Laminar Air Flow for dispensing and sampling booth Fortnightly Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. To observe the laminar flow in a water balloon, a square piece of tape is pasted on its surface. The air system should be provided with appropriate filters such as HEPA for grades A, B, and C. (b) The guidance given for the maximum permitted number of particles in the at rest condition corresponds approximately to the US Federal Standard 209E and the ISO classifications as follows: grades A and B correspond with class 100, M 3.5, ISO 5; grade C with class 10000, M 5.5, ISO 7 and grade D with class 100000, M 6.5, ISO 8. 4.3.8 Probe shall be held in a distance of approximately 3 cm from the downstream filter face or theframe structure. , Water Balloon. Switch ON the mains. SOP for RLAF Unit in Sampling Room : Pharmaguideline What is RLAF in pharma? Pol. It is a dynamic barrier of HEPA-filtered unidirectional air flow to move particles away from the filling/closing area. Handling of components, equipment, and accessories after washing, Assembly of cleaned components, equipment, and accessories before sterilization, Assembly of closed and sterilized SUS using intrinsic aseptic connectors. QC : Quality Control LAF: Laminar air flow. 4.3.7 Probe shall be adequate size. It does not store any personal data. ft. A critical location is defined as an area where product or material is exposed to the working environment. 5.2.17 After re-fixing the filters run the AHU and take the differential pressure reading across the filter for confirming the proper cleaning and integrity of the filters. 6.1 Record of AHU filter cleaning Annexure -1 Air flow turbulent 2.Protect material and man 3.Recirculated air LAF-1 air flow parrelel 2.Air flow once 3 protect material only Sajjad_Ahmad (Sajjad Ahmad) November 16, 2018, 3:39pm 3 kindly explain it trikam (T.L.Patel) October 19, 2020, 5:44pm 4 Why RLAF is used for sampling / dispensing of R.M. 3. packaging material Any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment. They are mandatory in sterile production, although they are sometimes also used in the manufacture of solid or semisolid dosage forms. Mail us at: info@pharmastate.com After completion of activity switch off the RLAF and mains electric supply. The key difference between laminar flow hoods and reverse laminar flow hoods is that the former protects items on the work surface while the latter protects operators. 5.2.7 Clean the plenum with dry cloth thoroughly and ensure that there is no dust accumulation in the plenum joint panels. Though a boundary layer of air sticks to a wing, the air overtop should be moving quickly and smoothly to reduce friction drag. What is most commonly used to clean a laminar flow hood? Reproduction and Distributionof the same without written permission is prohibited. After that spray 70% IPA and switch off the visible light and then switch ON the UV light till to start . (LAF). Holiday The major difference between laminar-flow chamber and biosafety cabinet is that air which comes out of the biosafety cabinet is filtered using HEPA filter (High Efficiency Particulate Air Filter), where in laminar-flow air blows out unfiltered so there is no protection for the laboratory worker. These cookies will be stored in your browser only with your consent. What is difference between LAF and RLAF? The key difference between laminar flow hoods and reverse laminar flow hoods is that the former protects items on the work surface while the latter protects operators. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. You can ask questions related to this post here. What is the association between H. pylori and development of. I love to write and share science related Stuff Here on my Website. Blog it! 9 What is the principle of reverse laminar air flow? 7.1 Master copy Documentation Cell (Quality Assurance) QA: Quality assurance Then switch off the light and Blower. We use cookies to ensure that we give you the best experience on our website. The main principal in the RLAF is "A negative pressure inside the booth prevents the escape of fine powder from the work area towards the external environment.Downward airflow provides full protection to operator and product". The mass median particle diameter of the aerosol particles shall bebetween 0.5 to 0.7 m. Non availability of machines/Area 4.1 Performance qualification shall be performed as per below frequency: 4.2 Pre-requisites for performance qualification are: 4.3 Filter Integrity test: GMP Facility: Understanding Grade A, Grade B, Grade C & D Save my name, email, and website in this browser for the next time I comment. It is also known as Sampling or Dispensing Booth. 0.3 microns Pore size of these filters is always 0.3 microns. 5.19 Store person shall weigh one material at a time in double polybags by scoops on balance. Cleaning of Pre-Filters, Microvee and Cartridge Filter 6.0 Forms and Records 2. Operation of Reverse Laminar Air Flow - Pharmaceutical Guidelines 6.0 PROCEDURE FOR FILTER CLEANING: difference between laf and rlaf in pharma. In a laminar flow hood the air is passed through a HEPA (High Efficiency Particulates Air) filter which removes all airborne contamination to maintain sterile conditions. Switch ON the RLAF. 5.2.9 Remove the filters from polythene bags and place the entire filter at the filter cleaning station for cleaning Purpose. It installed after the prefilters. 4.3.11 Acceptance criteria: Leaks are considered to have occurred if the reading is greater than0.01 % of the upstream challenge aerosol concentration. Please don't spam. Spams/ Promotional links are not allowed and shall be deleted upon review. What are the physical state of oxygen at room temperature? Turn the switch of the Air Flow to ON position. Comments having links would not be published. 4.4.4 The air flow velocity shall be measured with the help of vane type anemometer. Greenville, SC Reverse laminar air flow operates on the principle of providing containment of contaminated air by air movement. 10 What can reverse laminar airflow bench be used for? Is it easy to get an internship at Microsoft? Laminar airflow is working through air moving at the same speed and in the same direction, with no or minimal cross-over of air streams. The time period required to disturbed the cleanliness condition is noted. The airborne particle classification equivalent for Grade C (at rest and in operation) is ISO 7 and ISO 8, respectively. How many filters are in laminar air flow? This cookie is set by GDPR Cookie Consent plugin. PRESSURE DROP ACROSS PREFILTER FILTER 6 On completion of the operation, allow RLAF to run for 15 minutes. 3 consecutive readings for 1 minutes shall be taken and. In cases where operations are likely to cause defects in the final product, a higher degree of cleanliness is required to avoid contamination. Perform the test from 5 different locations. The pre-filter of RLAF unit are cleaned and Magnehelic gauges are calibrated. This is achieved by total removal of air borne droplet nuclei and dust-borne bacteria by unidirectional oriented streamlines of clean air at velocities designed to flush contaminating particulates. The filling of productsfor terminal sterilization(at least in a Grade C). All Rights Reserved. DOP test shall be carried out once in a year. Filling, Processing and Packaging, Particle level (> 0.5 m) less than 3,520 particles/m. Check the magnelic gauge, the needle should be at zero. Validation Team Members and their Signatures, Quality Assurance Department Certification. Laminar Flow Cabinets (tissue culture hood) work by the use of in-flow laminar air drawn through one or more HEPA filters, designed to create a particle-free working environment and provide product protection. 4.4.7 Acceptance Criteria : 90 20 feet per minute. 5.2 Cleaning of AHU filters: Box 4666, Ventura, CA 93007 Request a Quote: taurus 1911 45 acp extended magazine CSDA Santa Barbara County Chapter's General Contractor of the Year 2014! This means that whether employees are working or not, the cleanliness inside the cleanroom must maintain Grade A levels (ISO 5). RLAF: Reverse laminar air flow. The Laminar Flow Cabinet is maintained a constant positive air pressure to prevent the intrusion of contaminated room air. 208 Old Fork Shoals Rd These cookies ensure basic functionalities and security features of the website, anonymously. The instruments for performance qualification are in calibration state and Calibration certificates with traceability to national or international standards are available. The two equipment, however, bear other differences based on their usage, functionality and other aspects as explained below: Biological Safety Cabinet The Biological Safety Cabinet employs the HEPA filter mechanism in its exhaust system which traps different airborne materials. When used properly, air cleaners and HVAC filters can help reduce airborne contaminants including viruses in a building or small space. If you continue to use this site we will assume that you are happy with it. active pharmaceutical ingredients, packaging and labelling materials. Fill in this form and we will contact you as soon as possible. Applink-https://goo.gl/mS8Lr7. Blogg On It! Blog gone it! | Blogging For Bloggers APU : Air Processing Unit Antiscalant Solution, Preventive Maintenance of Rapid Cooling Steam Sterilizer, Preventive Maintenance of Rapid cooling steam Generator, sop for Preventive Maintenance of Dust Collector, SOP for Battery Backup in Mobile Laminar Air Flow Trolley, sop for Replacement of UV light of purified water plant, sop for Cleaning of soft water storage tank and RO feed tank, sop for Preparation of Sodium hydroxide Solution, sop for Operation and regeneration of softener plant, Procedure Of Issuance Of material from Engineering Store, sop for Preventive Maintenance of Filter Press, sop for Preventive Maintenance of Sugar Transfer System, sop for Preventive Maintenance of Shrink Sleeve Machine, sop for Preventive Maintenance of ROPP Cap Elevator, sop for Preventive Maintenance of Liquid Transfer Pumps, sop for Preventive Maintenance of Liquid Tanks, Preventive Maintenance of Strip De-Foiling Machine, sop for Preventive Maintenance of Colloidal Mill, sop for Preventive Maintenance of Packing Collator Belt, sop for Passivation of WFI Distribution Loop, sop for Analysis of Effluent Treatment Plant Water, sop for Methodology to Dispose ETP Sludge, sop for Action Plan In Case Of Electrical Power Failure, sop for Colour Coding of Piping and Accessories of Utilities, Filter Cleaning of HVAC System RLAF & LAF, Procedure for Calibration of Magnehelic Gauge, Procedure for Calibration of Vacuum Gauge, Procedure for Calibration of Pressure Gauge, sop for Procedure for Calibration of Temperature Controller, sop for Preventive Maintenance of Infrared Dryer Umbrella Type, sop for Preventive Maintenance of Battery stacker, sop for Preventive Maintenance of Vacuum Cleaner, sop for Preventive Maintenance of laminar air flow unit, sop for Preventive Maintenance of Lozenges Manufacturing Line, sop for Preventive Maintenance of Garment Washing Machine, sop for Preventive Maintenance of Multi Column Distillation Plant, sop for Preventive Maintenance of Steam Sterilizer Autoclave, sop for Preventive Maintenance of Pure steam Generator, sop for Preventive maintenance of Depyrogenating Tunnel, sop for Preventive Maintenance of vial sealing machine, sop for preventive maintenance of Powder Filling and Rubber Stoppering machine, sop for Preventive Maintenance of Vial Washing Machine, sop for Preventive Maintenance of Inspection Table, sop for Preventive Maintenance of Hi-Cart, sop for Preventive Maintenance of Turn table, sop for Preventive Maintenance of sticker labeling machine, sop for Preventive Maintenance of Liquid Filling and Sealing Machine, sop for Preventive Maintenance of Linear Bottle Washing Machine, sop for Preventive Maintenance of De-Foiling Machine, sop for Preventive Maintenance of Strip Packing Machine, sop for Preventive Maintenance of Blister Packing Machine, sop for Preventive Maintenance of Capsule Polishing and Sorting Machine, sop for Preventive Maintenance of Capsule Filling Machine, sop for Preventive maintenance of Auto Coater, sop for Preventive Maintenance of Compression Machine, sop for preventive maintenance of packing conveyor belt, sop for Preventive Maintenance of Sifter Cum Multi mill, sop for Preventive Maintenance of Rapid Mixer Granulator, sop for Preventive Maintenance Of Fluid Bed Dryer, sop for Preventive Maintenance of Octagonal Blender, sop for Preventive Maintenance of Lifting and Positioning Device, sop for Preventive Maintenance of Paste Preparation vessel, sop for preventive maintenance of Vibro-Sifter, sop for preventive maintenance of air curtain, sop for preventive maintenance of air handling units, Preventive Maintenance of Diesel Generator, sop for Preventive Maintenance of cooling towers, sop for Preventive Maintenance of Air Compressor, sop for Preventive Maintenance of Chilling Plant, sop for Preventive Maintenance of Transformers, sop for Preventive maintenance of Purified Water System, sop for Break Down maintenance of Machine and Work Requisition, sop for Operation of Dust Extraction System, sop for Operation Of Effluent Treatment Plant, sop for Operation of Multi Column Distillation Plant, sop for Operation of Pure Steam Generator, sop for Operation of Water Chilling Plant, sop for Sanitization of multi column plant, sop for Sanitization of Ultrafiltration System, Sop for Chemical Sanitization of Reverse Osmosis, Sop for Sanitization of Hot Sanitization & Electro Deionization unit, sop for Sanitization of Purified Water Loop, sop for preparation of sodium meta bisulphate solution, sop for Testing of Hardness of Soft Water, sop for Operation & back wash of multi grade filter, sop for testing of chlorine contents in water. A laminar flow cabinet is a carefully enclosed bench designed to prevent contamination of semiconductor wafers, biological samples, or any particle sensitive device. Low noise. Please, why does the RLAf have to be on for 15 minutes first? The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". What is Dispensing Booth? - Camomienoteca.com When installed, it will contribute greatly to maintaining or increasing air cleanliness levels. HEPA is an acronym for High Efficiency Particulate Air or High Efficiency Particulate Arrestance. This acronym refers to a filter that is manufactured, tested and certified to meet Institute of Environmental Sciences and Technology (IEST) construction, performance and certification standards as currently published . Different membranes should be used in different systems depending on their characteristics. 5.3.4 Repeat the procedure as mentioned in 5.2.7 to 5.2.17. Vertical Laminar Flow Hood Cleaning Steps. The Grade B cleanroom environment of your GMP facility is used for aseptic preparation and filling. In a pharmaceutical industry, Laminar Flow Cabinets are suitable for a variety of applications and especially where an individual clean air environment is required for particle sensitive products. What is a Laminar Flow unit? 5.2.10 Place the filters from the top on to the filter support frame with dirty side facing downward. List of Standard Operating Procedure (SOPs) in Production Oral, Procedure of Operation of Lux Meter and monitoring the Lux level, Pharmacist Want To "Drx" Prefix Before Name, Gracure Pharmaceuticals Openings for Production/ Packing/ QC/ QA/ PPIC/ IPQA/ QMS Apply Now, Vital Pharma -Walk-In Drive for Freshers & Experienced in QA/ Production/ QC/ Stores Dept. The airflow movement should be from Supply filter Diffuser to the Return Air Grill / Riser and most Positive area to the Negative area. The concentration of the aerosolshall be 20 80 mg/m3. The following tests shall be carried out by for PQ of LAF: V1 V2, V3 V4, Where, FPM is Feet per minute,CFM is Cubic Feet per minute, Air velocity should be 90 20 feet/minute. 5.1.2 Clean the external surface of the RLAF with a vacuum cleaner. 4.7.5 The Equipment is restarted; the particle count is taken every minute from the start. Performance Qualification LAF (Laminar Air Flow), SRF Limited -Walk-In Interviews for Production, Instrumentation, Electrical & Polymer Process On 20th & 21st May 2022, Establishing the minimal and maximal optimum speed during qualification of blender, Biocontamination control techniques in Purified Water System, SOP on Monitoring of Compressed air and Nitrogen for Microbial analysis, SOP on Sampling and testing procedure of swab sample, SOP on Preservative Efficacy Test of Oral Preparations. Examples of what activities should take place in a Grade C environment: Some of our Grade C Cleanroom past projects: cGMP Modular Cleanroom for Vaccine Plastic Components, GMP Cell Banking Cleanroom for Vaccine Production. Owing to its quality in adherence to the international quality standards, this cabinet is also widely used in various clean rooms & micro biological laboratories. 5.3.2 Take all the safety precaution prior to cleaning the APU filters of FBD and Coating. 5.4.8 Place the filters from the top on to the filter support frame with dirty side facing downward. TAC : Tablet and Capsule 5.4.10 Record the cleanliness of filter as shown in Annexure 5 The most common filter membrane types are reverse osmosis, ultrafiltration, and nanofiltration. The laminar flow hood depends on the laminar air flow to sweep away pathogens from the hood. Laminar Air Flow (LAF) Work Station is capable of maintaining a particulate free work area even when operated in an uncontrolled environment. 5.2.13 Dry the filter by blowing compressed air in the direction to that of normal air flow direction. 5.2.19 Record the cleanliness of filter as shown in Annexure 1, 2, 3&4. The device works by the use of inwards flow of air through one or more HEPA filters to create a particulate-free environment. Most contamination-sensitive environments in a pharmaceutical industry such as dust-free hoods require laminar flow because it predictably sweeps particles in a uniform direction, from the cleanest area under the hood. Discard the used polythene bag. Industrial HEPA filters or High-Efficiency Particle Air filters are an essential part of the pharmaceutical and healthcare industries, where sterile environments are mandatory. Home / Learning center / GMP Facility: Understanding Grade A, Grade B, Grade C and D, GMP Facility: Understanding Grade A, Grade B, Grade C & D. Understanding the GMP requirements and their grades can be challenging at times, especially with different regulatory bodies in other countries. The major difference between laminar-flow chamber and biosafety cabinet is that air which comes out of the biosafety cabinet is filtered using HEPA filter (High Efficiency Particulate Air Filter), where in laminar-flow air blows out unfiltered so there is no protection for the laboratory worker. The device works by the use of inwards flow of air through one or more HEPA filters to create a particulate-free environment. If theresults are found to be within the specified limits, affix qualification status labels. Holiday The air flow in the RLAF system should be re-circulated. 5.3.3 Take out the unclean filters from respective APU unit of FBD or Coating. 3.3 Head QA/Designee should be responsible for compliance of this SOP.

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