《BS-5295-PART-4-1989.pdf》由会员分享，可在线阅读，更多相关《BS-5295-PART-4-1989.pdf（12页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS 5295-4: 1989 Environmental cleanliness in enclosed spaces Part 4: Specification for monitoring clean rooms and clean air devices to prove continued compliance with BS 5295-1 UDC 725.4.055:658.2:628.511.052:679.94 Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:07 GMT
2、+00:00 2006, Uncontrolled Copy, (c) BSI BS 5295-4:1989 This British Standard, having been prepared under the direction of the Laboratory Apparatus Standards Policy Committee, was published under the authority of the Board of BSI and comes into effect on 29 September 1989 BSI 12-1998 The following BS
3、I references relate to the work on this standard: Committee reference LBC/30 Draft for comment 88/55585 DC ISBN 0 580 17615 0 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Laboratory Apparatus Standards Policy Committee (LBC/-) to Tech
4、nical Committee LBC/30, upon which the following bodies were represented: Association of the British Pharmaceutical Industry British Occupational Hygiene Society British Surgical Trades Association Incorporated British Telecommunications plc Chartered Institution of Building Services Engineers Depar
5、tment of Health HM Treasury (Central Computer and Telecommunications Agency) Heating and Ventilating Contractors Association Institute of Environmental Science and Technology Institute of Sterile Services Management Medical Sterile Products Association Ministry of Defence Parenteral Society Society
6、of British Aerospace Companies Limited Society of Environmental Engineers Surgical Dressings Manufacturers Association United Kingdom Atomic Energy Authority User Standards Forum for Information Technology (Institute of Data Processing Management) Amendments issued since publication Amd. No.DateComm
7、ents Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5295-4:1989 BSI 12-1998i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2Definitions1 3Monitoring procedures1 4Operational procedures and documentation3 5Reva
8、lidation3 Appendix A Summary table of minimum monitoring frequencies4 Appendix B Guidance on microbiological monitoring4 Table 1 Frequencies for monitoring air pressure difference2 Table 2 Frequencies for monitoring installation leak2 Table 3 Frequencies for monitoring particulate contamination2 Tab
9、le 4 Summary table of minimum monitoring frequencies4 Publications referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5295-4:1989 ii BSI 12-1998 Foreword IMPORTANT NOTE.It is essential that this Part is read in c
10、onjunction with BS 5295-O, issued separately This Part of BS 5295 has been prepared under the direction of the Laboratory Apparatus Standards Policy Committee. This is a new Part resulting from the perceived need from various quarters, particularly regulatory authorities and others concerned with qu
11、ality assurance, to provide a mechanism to prove continued compliance with BS 5295-1. This Part specifies minimum requirements for monitoring based on a compromise between what is desirable and what is feasible. In any monitoring scheme, consideration should also be given to the particular operation
12、al requirements of the installation and its use, e.g. the products being produced in it, and to the general guidance on operational procedures given in BS 5295-3. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for
13、 their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 6, an inside back cover and a back cover. This standard has been updated
14、 (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5295-4:1989 BSI 12-19981 1 Scope This Part of BS 5295
15、 specifies requirements for monitoring clean rooms and clean air devices to prove their continued compliance with BS 5295-1, for the designated class of environmental cleanliness. This Part may also be applied to the monitoring of controlled spaces on the basis of an agreed cleanliness specification
16、. NOTEThe titles of the publications referred to in this standard are listed on the inside back cover. 2 Definitions For the purpose of this Part of BS 5295, the definitions given in BS 5295-0 apply together with the following. 2.1 frequency intervals 2.1.1 continuous providing a continuous display,
17、 updated at intervals not exceeding 120 s 2.1.2 hourly at an average interval not exceeding 1 h throughout periods of operational use, subject to no interval exceeding 75 min 2.1.3 daily at an average interval not exceeding 24 h throughout periods of operational use, subject to no interval exceeding
18、 32 h 2.1.4 weekly at an average interval not exceeding 7 days throughout periods of operational use, subject to no interval exceeding 8 days 2.1.5 monthly at an average interval not exceeding 30 days throughout periods of operational use, subject to no interval exceeding 35 days 2.1.6 quarterly at
19、an average interval not exceeding 92 days throughout periods of operational use, subject to no interval exceeding 100 days 2.1.7 half-yearly at intervals not exceeding 183 days throughout periods of operational use, subject to no interval exceeding 190 days 2.1.8 yearly at an average interval not ex
20、ceeding 366 days throughout periods of operational use, subject to no interval exceeding 400 days 2.2 revalidation a repeat of the test sequence specified in clause 6 of BS 5295-1:1989 to demonstrate compliance with BS 5295-1 in all respects 3 Monitoring procedures 3.1 General In order to prove cont
21、inued compliance with BS 5295-1, tests for air pressure difference, installation leak, induction leak and particulate contamination shall be carried out and the results indicated, checked or recorded as relevant at the intervals specified in 3.2 to 3.5 for the designated class of environmental clean
22、liness for the controlled space concerned. NOTE 1A summary table of the minimum monitoring frequencies is given in appendix A. All tests shall be carried out in the relevant state or states of occupancy (see 4.16 of BS 5295-0:1989) specified in the purchase specification for the installation or in a
23、ny subsequently agreed and documented specification. The calibration of the apparatus used in the tests shall be traceable to national standards1). NOTE 2In medical and pharmaceutical applications it is also general practice to carry out routine microbiological monitoring. Guidance concerning microb
24、iological monitoring is given in appendix B. 3.2 Air pressure test NOTEThis subclause does not apply to clean air devices which are not totally enclosed. 3.2.1 Monitoring schedule: The air pressure shall be tested following the procedure of appendix B of BS 5295-1:1989 or using an instrument calibra
25、ted against the manometer specified in B.2.1 of BS 5295-1:1989. 1) In the United Kingdom traceability is through the National Measurement Accreditation Service (NAMAS). Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5295-4:1989 2 BSI 12-
26、1998 The test shall be carried out at a frequency as given in Table 1. Table 1 Frequencies for monitoring air pressure difference 3.2.2 Remedial action. If the air pressure difference between the classified and unclassified areas or adjacent classified areas falls to less than the value given in Tab
27、le 2 of BS 5295-1:1989, without total loss of pressure or reversal of air flow, for a period greater than 1 h for rooms classified as classes C to F, or greater than 4 h for classes G to J, or greater than 8 h for classes J to M, remedial work shall be carried out to return the installation to a sta
28、te of compliance with 6.2.2 of BS 5295-1:1989. If a total loss of pressure or reversal of air flow occurs, remedial work shall be carried out to return the installation to a state of compliance. This remedial work shall include any adjustments to the various systems associated with the controlled en
29、vironment, e.g. adjustments to the air movement system. When the remedial work has been completed, the particulate contamination shall be tested following the procedure of appendix E or F of BS 5295-1:1989 depending on the class, to establish that the installation complies with the requirements of 6
30、.2.5 of BS 5295-1:1989 for the designated class. NOTEIn installations where routine microbiological monitoring is carried out, it will be necessary to retest following the guidance given in appendix B. 3.3 installation leak test 3.3.1 Monitoring schedule. The installation leak test shall be carried
31、out following the procedure of appendix C of BS 5295-1:1989 at a frequency as given in Table 2. Table 2 Frequencies for monitoring installation leak 3.3.2 Remedial action. If the installation fails to comply with the requirements of 6.3.2 of BS 5295-1:1989, remedial work shall be carried out to retu
32、rn the installation to a state of compliance. This remedial work shall include any adjustments to the various systems associated with the control environment, e.g. adjustments to the air movement system. When remedial work has been completed, the particulate contamination shall be tested following t
33、he procedure of appendix E or F of BS 5295-1:1989 depending on the class, to establish that the installation complies with the requirements of 6.2.5 of BS 5295-1:1989 for the designated class. 3.4 Induction leak test 3.4.1 Monitoring schedule. The induction leak test shall be carried out on revalida
34、tion following the procedure of appendix D of BS 5295-1:1989 for all classes of clean rooms and clean air devices. 3.4.2 Remedial action. If the installation fails to comply with the requirements of 6.4.2 of BS 5295-1:1989 it shall be considered to be in a state of non-compliance until leaks have be
35、en repaired and repeat tests have been carried out to prove otherwise. 3.5 Particulate contamination test 3.5.1 Monitoring schedule. The particulate contamination shall be tested following the procedure of appendix E or F of BS 5295-1:1989 depending on the class, unless a device with a calibrated co
36、ntinuous particulate monitoring capability is in operation, in which case the data collected from this shall be acceptable. The test or data recording shall be carried out at a minimum frequency as given in Table 3. The test shall also be carried out where there has been a closedown of the air movem
37、ent system exceeding 2 days for rooms or 1 week in the case of devices. NOTEFor critical processes or products the frequencies in Table 3 may need to be increased. Consideration should also be given to the monitoring requirements of regulatory authorities. Table 3 Frequencies for monitoring particul
38、ate contamination ActionClassFrequency IndicationAll classes Continuous CheckHourly Recording of deviations or compliance Every 8 h of operational use or hourly during periods of non-compliance ActionClassFrequency Test and recordC to FHalf-yearly G to JYearly K to MOn revalidation ActionClassMinimu
39、m frequency Test and recordC and DDaily E and FWeekly G to JMonthly K to MQuarterly Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5295-4:1989 BSI 12-19983 3.5.2 Remedial action. If the installation fails to comply with the requirements
40、of 6.2.5 of BS 5295-1:1989 it shall be considered to be in a state of non-compliance until remedial action has been undertaken and repeat tests have been carried out to prove otherwise. 3.6 Records For the purposes of this Part of BS 5295, monitoring records detailing the results of the tests descri
41、bed in 3.2 to 3.5 shall be kept for a rolling period of not less than 5 years. 4 Operational procedures and documentation The user shall prepare a document scheduling the procedures to be followed by all those involved with the operation of the installation. Any breach of the procedures listed in th
42、e document shall result in a declassification of the installation, at least for the duration of the breach and until tests have been carried out to prove otherwise. The document shall include at least the following information: a) the original purchase specification, or any subsequently agreed and d
43、ocumented specification prepared in accordance with BS 5295-2; b) monitoring procedures; c) responsibilities; d) operational procedures and disciplines. A copy of the document shall be kept with the records concerning the performance of the installation (see 3.6). NOTEGuidance on operational procedu
44、res and disciplines is given in BS 5295-3. 5 Revalidation Revalidation shall be carried out when any of the following occur: a) any change outside the range of the original purchasing specification as described in clause 3 of BS 5295-2:1989, e.g. a change of operational use or a change in maximum sp
45、ecified occupancy level; b) any closedown of air movement systems for a period exceeding 7 days for rooms classified as classes C to J, or 14 days in the case of rooms classified as classes K to M, or one month in the case of clean air devices; c) any change in the location of a clean air device; d)
46、 after special maintenance or change of final filters. Revalidation shall be carried out at least once a year unless it has been carried out as a result of the changes, listed in a) to d), during the previous 12 months. Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:07 GMT+00:00 2006,
47、Uncontrolled Copy, (c) BSI BS 5295-4:1989 4 BSI 12-1998 Appendix A Summary table of minimum monitoring frequencies A summary of the minimum monitoring frequencies is given in Table 4. Table 4 Summary table of minimum monitoring frequencies Appendix B Guidance on microbiological monitoring B.1 Genera
48、l B.1.1 For particular applications, the level of microbiological contamination of a controlled environment facility may be of greater importance than the level of particulate contamination. Where this is so, the limits for microbiological contamination to be met under defined operating conditions s
49、hould be specified by the user. B.1.2 For certain operations, consideration should be given to the microbiological monitoring of facilities or individual work stations in the manned state. B.1.3 When limits for microbiological contamination have been specified for defined areas and defined conditions, then routine microbiological monitoring should be carried out to prove continued compliance with any such requirements. B.1.4 There should be a documented procedure defining the monitoring required; any limits to be met and action required in the event of such li