1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12461:1998 The Euro
2、pean Standard EN 12461:1998 has the status of a British Standard ICS 07.080; 13.030.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Large-scale process and production Guidance for the handling, inactivating and testing of wasteThis British Standard, having bee
3、n prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 July 1998 BSI 1998 ISBN 0 580 29846 9 BS EN 12461:1998 Amendments issued since publication Amd. No. Date Text affected National forewor
4、d This British Standard is the English language version of EN 12461:1998. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enqui
5、ries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The Brit
6、ish Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A Britis
7、h Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for 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
8、cover, an inside front cover, the EN title page, pages 2 to 11 and back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and b
9、y any means reserved worldwide for CEN national Members. Ref. No. EN 12461:1998 E EUROPEAN STANDARD EN 12461 NORME EUROPE ENNE EUROPA ISCHE NORM February 1998 ICS 07.080; 13.030.01 Descriptors: biotechnology, work safety, accident prevention, environmental protection, waste treatment, wastes, solids
10、, effluents, gaseous effluents, sterilization, disinfection, incineration (waste), irradiation, hazards, contamination English version Biotechnology Large-scale process and production Guidance for the handling, inactivating and testing of waste Biotechnologie Proce de a grande e chelle et production
11、 Guide pour la manipulation, linactivation et le contro le des de chets Biotechnik Verfahren in Gromastab und Produktion Leitfaden zur Handhabung, Inaktivierung und Pru fung von Abfall This European Standard was approved by CEN on 31 January 1998. CEN members are bound to comply with the CEN/CENELEC
12、 Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN
13、member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN mem
14、bers are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12461:1998 BSI 1998 Foreword This European Standard has b
15、een prepared by Technical Committee CEN/TC 233, Biotechnology, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 1998, and conflicting national stan
16、dards shall be withdrawn at the latest by August 1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Icelan
17、d, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Definitions 3 3 Waste management policy 4 4 Characterization of waste stream 4 5 Establishment of procedures 4 6 Waste treatment method
18、s 7 7 Risk management 7 Annex A (informative) Example of a continuous effluent sterilization by a thermal inactivation system 9 Annex B (informative) Examples of application of disinfectants 11 Annex C (informative) Bibliography 11Page 3 EN 12461:1998 BSI 1998 Introduction This European Standard sup
19、ports industrial activities in the area of biotechnology covering operations both non-genetically modified and genetically modified microorganisms and with both non-pathogenic and pathogenic microorganisms (see annex C 1, 2). International, national and local rules, guidelines, safety regulations an
20、d instruction manuals that deal with the handling of microorganisms in all steps of fermentation and downstream processes, as well as those used in environmental biotechnology, should be considered. 1 Scope This European Standard gives guidance on the assessment and the selection of procedures for t
21、reatment of waste process microorganisms from biotechnological plant to ensure the safety of people and the environment. This European Standard applies to wastes and effluents (solid, liquid and gaseous) emitted from biotechnological processes which include traditional processes such as brewing or f
22、ood processing, and fermentation for pharmaceutical and chemical products, as well as biotechnological processes for environmental and agricultural application. This European Standard for biotechnological processes is only applicable until gas, liquids and solids are ready for safe transfer to norma
23、l industrial or municipal waste handling units. This European Standard is not applicable to the waste from hospitals, nor to the treatment of chemical and physical hazardous waste. NOTE Attention is drawn to relevant national regulations. 2 Definitions For the purposes of this standard, the followin
24、g definitions apply. 2.1 biohazardous waste biological waste which can cause a hazard 2.2 cell culture in vitro growth of cells derived from multicellular organisms 2.3 disinfectant chemical agent which is able to reduce the number of viable microorganisms 2.4 disinfection process of reducing the nu
25、mber of viable microorganisms by various physical and chemical methods 2.5 hazard intrinsic potential property or ability of something (e.g. any agent, equipment, material or process) to cause harm EN 1620 NOTE Harm is an injury or damage to health of people and/or to the environment. 2.6 microorgan
26、ism any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 1619 NOTE For the purposes of this standard, the term microorganism covers the term of biological agent, according to the directive 90/679/EEC: microorganisms, including those whic
27、h have been genetically modified, cell cultures and human endoparasites which may be able to provoke any infection, allergy or toxicity. 2.7 inactivation process used to reach a state free of a viable process microorganism 2.8 physical containment system for confining a microorganism or organism or
28、other entity within a defined space EN 1620 2.9 process microorganism microorganism used for production purposes in a biotechnological process or constituting (part of) the product itself 2.10 sterile state of being free from viable microorganisms NOTE 1 In practice, no such absolute statement regar
29、ding the absence of viable microorganisms can be proven. However, sterile conditions can be regarded as established by using an accepted or recognized method of sterilization. NOTE 2 The process of inactivation of viable microorganisms during a sterilization procedure is usually described by an empi
30、rical mathematical function, commonly an exponential function. By their mathematical nature, such functions can be reduced to very low numbers, but not to zero. However, these empirical functions can be applied to control or assess the process parameters of a sterilization procedure to realize a des
31、ired degree of inactivation of viable microorganisms. 2.11 sterilization process used to reach a sterile state 2.12 validation documented procedure for obtaining, recording and interpreting the results needed to show that a process will constantly yield a product complying with predetermined specifi
32、cations 2.13 verification assay assay used to determine whether material meets the intended specifications 2.14 waste by-product arising from a process, or unwanted substance or article derived from any activity NOTE Examples of waste are scrap material, effluent, unwanted residue or surplus arising
33、 from any process or activity, or any substance or article which is discarded or to be disposed of as being broken, contaminated, spoiled, or worn outPage 4 EN 12461:1998 BSI 1998 3 Waste management policy The production of waste should be minimized and, if possible, the recovery of materials should
34、 be attempted. A documented waste management policy should be established, describing the measures for prevention, minimization, segregation, handling, storage, treatment, re-use, transportation and disposal of waste from a large-scale biotechnological process. The waste management system and the re
35、sponsibilities and duties allocated to managers, supervisors and employees should be specified. The arrangements for effective control of biohazardous waste should be integrated with general management and supervisory organization within the production process. Documented operational procedures, des
36、cribing the methods used for effective waste management should be established. These documents should be reviewed at regular intervals and updated, if necessary. Attention is drawn to international, European and national requirements for the control of waste. A description should be given of the met
37、hods and procedures for handling, inactivating and treating waste for both normal conditions and deviations. It is also necessary to describe the commissioning, maintenance and use of plant and equipment in accordance with other appropriate biotechnological European Standards and guidelines. Compreh
38、ensive information should be provided on the risks to health and safety arising from waste which contains pathogenic microorganisms, together with details of its treatment and the prevention and control measures which are used in normal and emergency procedures. This information should be understand
39、able to technical and non-technical personnel alike. The waste management plan, together with the practical arrangements for the control, treatment and disposal for waste, should be subject to a quality assurance and control programme or equivalent systematic monitoring and auditing programme. The q
40、uality of the waste management system should be assured by periodic checks and inspections of the various arrangements and procedures. These include operating conditions and control devices of plant and equipment, the composition and characterization of the waste loads, and adherence to approved sta
41、ndard operating procedures. Test and inspection results should be documented, together with details of any action taken to correct deviations from the intended operating conditions. The results and documentation of quality assurance or audit programmes should be submitted to the internal supervising
42、 office. 4 Characterization of waste stream The following are essential elements, which should be included and documented in a waste management plan: definition of the physical and chemical parameters which can affect the choice of treatment and testing methods, such as the amount of suspended solid
43、s or pH; methods for the segregation of biohazardous waste from non-biohazardous waste at the point of origin, if possible; methods for the segregation of other categories of waste (such as hazardous chemical or radioactive products) which do not contain microorganisms when there is incompatibility
44、with the biohazardous waste treatment methods. A detailed statement should be given of the various activities, processes and the types of waste that are subject to the waste management plan (see Figure 1). 5 Establishment of procedures The procedures for appropriate treatment of waste steam should b
45、e developed. Figure 2 shows the main steps to be conisdered to guide the choice of waste treatment procedures.Page 5 EN 12461:1998 BSI 1998 Figure 1 Identification of waste streamsPage 6 EN 12461:1998 BSI 1998 Figure 2 Establishment of proceduresPage 7 EN 12461:1998 BSI 1998 6 Waste treatment method
46、s 6.1 General The choice of methods should take into account the category of microorganism, determined in accordance with national, European or international classification rules, the objectives of the treatment (minimize or prevent) and the following criteria: efficiency of the method; process-spec
47、ific operation conditions; interference with other process parameters; maintenance conditions. Different methods can be used. The inactivation process, which can combine different methods of treatment, should be validated and documented. Any change relevant to safety in the process should be reviewe
48、d, validated as necessary and documented (see Table 1). Table 1 Example of waste treatment methods related to the type of waste Treatment Type of waste Gas Liquid Solid Thermal X 1) XXX 3) XXX Chemical XX 2) XX XX Irradiation X X X Incineration XX X XXX Filtration XXX X N/A 4) Biological X XX X 1) X
49、 possible 2) XX appropriate 3) XXX recommended 4) N/A not applicable 6.2 Thermal treatment The combination of temperature and time is critical for the effectiveness of the thermal treatment. A number of factors also influence the success of thermal treatment, such as the number and type of microorganisms present, the composition of the liquid and solid phases, the pH value and water activity. NOTE Some examples are given as follows: for the majority of non-sporulating process microorganisms, temper
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