Labsystem Clean Room Technology Room Pressure Controllers-Books Pdf

LabSystem Clean room technology Room pressure controllers
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Clean room technology Room pressure controllers, Chapter 7 0. Table of contents, Section Title Page, 6 2 2 Influence of the control tolerance of a volume flow controller 11. 6 2 3 Sample calculation with a room leakage of 0 001 m 10 cm with equal supply. air and exhaust air volume flow 12, 6 2 4 Sample calculation with a room leakage of 0 01 m 100 cm with equal supply. air and exhaust air volume flow 12, 6 2 5 Sample calculation for a defined positive room pressure of 10 pa with a. room leakage of 0 01 m 100 cm 13, 6 2 6 Conclusion room pressure control with volume flow controllers 13.
6 3 Room pressure control of an airtight room 13, 6 3 1 Influence of the control tolerance of a room pressure controller 14. 6 3 2 Sample calculation with a room leakage of 0 001 m 10 cm with constant. supply air volume flow and room pressure controllers 14. 6 3 3 Sample calculation with a room leakage of 0 01 m 100 cm with constant. supply air volume flow and room pressure controllers 14. 6 4 CRP room pressure controller with double control accuracy 14. 6 5 Observation of the control speed of the CRP room pressure controller 15. 6 6 Control of airtight rooms with the VCP volume flow prioritised room. pressure controller 16, 6 6 1 Sample calculation with a room leakage of 0 001 m 10 cm with constant. supply air volume flow and VCP volume flow prioritised room pressure controller 16. 7 1 VCP volume flow prioritised room pressure controller 17. 7 1 1 Control speed of the VCP controller 17, 7 1 2 Control accuracy of the VCP controller 17. 7 1 3 Room plan VCP 18, 8 1 PM 100 room pressure monitor 20. 9 1 Volume flow controller VAV 21, 9 1 1 Control speed of the VAV controller 21.
9 1 2 Control accuracy of the VAV controller 21, 10 1 Performance features CRP room pressure controller 23. 10 2 Performance features VCP volume flow prioritised room pressure controller 24. 10 3 Performance features PM100 room pressure monitor 25. 10 4 Performance features VAV volume flow controller 25. 11 1 Product overview Room pressure controllers Volume flow controllers. Room pressure monitors 26, 2 LabSystem Planning Manual Air technology for laboratories. Clean room technology Room pressure controllers, Chapter 7 0. 1 1 What is clean room technology, In many manufacturing sectors increasingly more deman According to the GMP requirements guidelines for quali. ding industrial requirements result in the use of extraordi ty assurance of the production processes and production. narily sophisticated technologies and process techniques environment during the production of pharmaceutical pro. and the methods used are continuously becoming more ducts active substances and medical products as well as. precise and effective In order to fulfil market demands foodstuffs and animal feed clean room technology must. to produce top quality while at the same time using mass provide ventilation systems for pharmaceutical genetic. production much stricter general manufacturing require and biotechnology pharmacies and laboratories This re. ments must be adhered to such as the requirement to quires a great deal of knowledge and know how. keep production plants free of dust and germs, Table 7 2 lists the correlations between the US VDI and.
One can no longer imagine any modern high tech industry ISO classes. that does not have the production requirement for clean. room technology as a chain of all measures for the pre. vention or reduction of harmful influences on products or US FS 209b VDI 2083 DIN ISO 14644. Class 0 01 ISO Class 1, Clean room technology Class 0 1 ISO Class 2. Class 1 VDI Class 1 ISO Class 3, keeps the working area clear of particles from the. surrounding air Class 10 VDI Class 2 ISO Class 4, guarantees air filtering and air flow routing Class 100 VDI Class 3 ISO Class 5. offers different levels of negative and positive pressu Class 1 000 VDI Class 4 ISO Class 6. re between, rooms and room types Class 10 000 VDI Class 5 ISO Class 7. maintains specific air conditions such as temperature. and Table 7 2 Correlation of the US VDI and ISO classes. makes it possible to add high purity media US Class 100 corresponds to VDI Class 3 and defines a. to the process particle concentration of max 100 particles with a size of. ensures clean room compatible production more than 0 5 m per foot while DIN ISO Class 5 defi. technology and processes nes a particle concentration of max 3520 particles with a. guarantees surface cleanness of the products size of more than 0 5 m per m. working surfaces and packaging, discharges and disposes of the process exhaust air.
promotes behaviour on the part of the personnel that 1 2 Good Manufacturing Practice. is adapted to the process and product, and provides the necessary GMP Good Manufacturing Practice provides guidelines. motivation and training for quality assurance of the production processes and pro. duction environment during the production of pharmaceu. The international standards ISO 14644 1 and VDI 2083 tical products active substances and medical products. define the Classification of Air Cleanliness The US Fe and also foodstuffs and animal feed. deral Standard 209b has been replaced by the standards. DIN ISO 14644 1 and DIN ISO 14644 2 Table 7 1 lists for In pharmaceutical manufacturing quality assurance plays. each ISO class the maximum value for particle concentra a central role because here variations in quality can have. tion particles per m a direct impact on the health of consumers. Maximum values for particle concentration particles per m. Class 0 1 m 0 2 m 0 3 m 0 5 m 1 m 5 m, ISO 1 10 2, ISO 2 100 24 10 4. ISO 3 1 000 237 102 35 8, ISO 4 10 000 2 370 1 020 352 83. ISO 5 100 000 23 700 10 200 3 520 832 29, ISO 6 1 000 000 237 000 102 000 35 200 8 320 293. ISO 7 352 000 83 200 2 930, ISO 8 3 520 000 832 000 29 300.
ISO 9 35 200 000 8 320 000 293 000, Table 7 1 ISO Classification of Air Cleanliness. LabSystem Planning Manual Air technology for laboratories 3. Clean room technology Room pressure controllers, Chapter 7 0. A quality management system that meets the GMP re Control accuracy of the volume flow controller and. quirements guarantees product quality and the fulfillment volume flow difference supply air exhaust air. of the obligatory requirements imposed by health authori Running time and possible hysteresis of the. ties for the marketing of the products actuators used. 1 3 Minimum requirements of the rooms 1 6 The room leakage. Clean room classes are based on the supplementary gui The room leakage is usually caused mainly by door ope. deline to the EU GMP code of practice for the manufactu nings and pipes fed into walls untight windows and conce. re of sterile pharmaceutical products Critical work steps aled wires in the room interior e g electrical installations. must be carried out in an area that corresponds to Clean in pipes. Room Class A highest requirement, Increasingly airtight construction methods mean that the. The controlled area should preferably meet the criteria of se natural balancing openings are no longer present In. Class B with appropriate evidence a room corresponding creasingly airtight rooms are very difficult to control with. to Class C may be sufficient When an isolator is used regard to room pressure maintenance see section 6 1. Clean Room Class D is sufficient ff To prevent this overflow openings are purposely built. in but these must not be too narrow or sharp edged as. Access to the controlled area should take place via a room this would result in whistling noises. that serves as an air lock the doors must be bolted shut. against each other Material should be introduced separa If an air change in the wrong direction must be avoided. tely from personnel e g via a materials air lock when the unit is switched off the opening must be sup. plied with a weighted or spring loaded check valve. 1 4 Clean room hierarchies, 1 7 Pressure difference in relation to the. Access to the cleanest room usually takes place via a se surroundings. ries of different clean room areas with decreasing clean. room class Normally clothes are changed between these Under the application of fluidics the pressure drop via the. areas To keep contamination of objects that come into room leakage behaves almost quadratically to the flow. contact with the floor e g shoe soles to a minimum spe rate This is why the resulting pressure difference in re. cial adhesive foot mats are placed in the individual access lation to the surroundings due to an unbalanced volume. points In addition access to the cleanest room itself takes flow can be determined If compensation takes place via. place via personnel and material air locks in which strong a defined overflow opening the resistance of the overflow. air flows and filter systems disperse and extract existing element is to be equated with the pressure difference see. particles so that no additional contaminants from outside the Bernouilli formula section 6 1 ff. are brought in, 1 8 Room pressure ratio with different.
supply air and exhaust air volume flows, 1 5 The room pressure. If for example constant positive pressure in relation to the. Doors windows and wall openings are sealed in order to surroundings should be maintained an air surplus should. prevent an exchange of air between the laboratory and be planned accordingly The exhaust air volume flow con. its surroundings for environmental hygiene or safety re troller must be less than the supply air volume controller. asons However this not only prevents air exchange but by the outflowing part The volume flow difference is cal. also pressure compensation with the surroundings which culated as follows. can result in inadmissible pressure differences, Conditions in relation to the surroundings only remain con Volume flow difference supply air exhaust air. stant when the supply air and exhaust air volume flows. are equally high Assuming a typical maximum variance. of the volume flow controllers of 5 percent during con Room pressure control with volume flow controllers is only. trol operation the usual room air tightness values are not suitable when there is a sufficiently large room leakage as. a problem with today s building standards However as the following example demonstrates. soon as increasing emphasis is placed on the air tightness. of the building undesired pressure differences arise Assumptions. Room supply air 1500 m h, The resulting room pressure is dependent on the following Room exhaust air 1360 m h. parameters Volume flow difference 140 m h, Room leakage area 0 01 m. Size of the room leakage area Control variance of one controller 5. Area of the overflow opening Consolidated control variance. Set ratio of the supply and exhaust air of both controllers 7 5. volume flow, 4 LabSystem Planning Manual Air technology for laboratories.
Clean room technology Room pressure controllers, Chapter 7 0. This example shows that now a volume flow of 140 m h Clean room class Volume flow Air changes. must escape through leakages The size of the opening according to m hxm Number h. determines the resulting pressure difference in relation to US FS 209b. the surroundings not taking the control variance into ac. count 10 1 600 1 800 500 600, 100 1 600 1 800 500 600. Taking into account the control inaccuracy of the volume 1 000 700 1 100 200 300. flow controllers a fluctuation range differential volume. flow of 140 m h 112 5 m h can be expected As a re 10 000 60 120 20 40. sult e g with an opening area of 0 01 m for example the 100 000 60 20. pressure fluctuations listed in Table 7 1 arise see Diagram. 7 1 in section 6 All specifications are recommended values. Volume flow Differential Pressure Table 7 2 Air changes for various clean rooom classes. supply air volume flow difference, m h m h Pa The lower the permitted particle contamination the. VMIN 1500 112 5 27 5 0 67 more often the air must be changed. VMED 1500 140 17 5, VMAX 1500 112 5 252 5 56 9 2 1 Laminar Flow. Table 7 1 Pressure fluctuations in the case of a room. The underlying idea of low turbulence displacement flow. leakage of 0 01 m and the given values, laminar flow is that particles are transported along with.
the flow lines Since all flow lines are laid from top to bot. tom lateral dispersion of the particles is not possible and. The pressure difference range of 0 67 to 56 9 Pa is not contaminations are immediately removed from the air. acceptable for stable room pressure control Possible. measures that can be taken include increasing the room Together with usually multi stage filtering and a high air. leakage or controlling room pressure maintenance with flow rate the cleanliness of the air should be guaranteed. CRP room pressure controllers see section 5 1 ff or for. critical room pressure control situations with a very small. room leakage area with SCHEIDER s patented VCP volu Supply air. me flow prioritised room pressure controller, 2 0 Air changes and air flow routing. Table 7 2 shows the air changes for various clean room. During daytime operation a laboratory typically requires Exhaust. 8 room air changes of 25m h x m The demanding re, quirements of clean rooms with room air change rates of. 20 to 600 quickly become apparent i e 2 5 to 75 times. higher air change rates than are required in laboratories. The particle contaminated air is displaced by air with. 3 Clean room technology Room pressure controllers Chapter 7 0 LabSystem Planning Manual Air technology for laboratories 1 1 What is clean room technology

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