BS EN 17141:2020
$198.66
Cleanrooms and associated controlled environments. Biocontamination control
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 54 |
This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.
This document is limited to viable microbiological contamination and excludes any considerations of endotoxin, prion and viral contamination.
There is specific guidance given on common applications, including Pharmaceutical and BioPharmaceutical, Medical Devices, Hospitals and Food.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 10 | 1 Scope 2 Normative references 3 Terms and definitions |
| 13 | 4 Establishment of microbiological control 4.1 General 4.2 Establishing a formal system for microbiological control |
| 14 | 4.3 Microbiological contamination control system quality attributes 4.4 Identification of all potential sources and routes of microbiological contamination 4.4.1 General |
| 15 | 4.4.2 Sources of microbiological contamination 4.4.2.1 General 4.4.2.2 Prime sources 4.4.2.3 Derived or associated sources 4.4.3 Routes of transfer of microbiological contamination |
| 16 | 4.5 Risk assessment 4.6 Establishment of microbiological environmental monitoring plan 4.6.1 General 4.6.2 Monitoring locations 4.6.3 Monitoring frequencies |
| 17 | 4.7 Establishment of alert and action limits 4.8 Establishment of documentation system 4.9 Personnel education and training |
| 18 | 5 Demonstration of microbiological control 5.1 Trending 5.2 Verification of the formal microbiological control system 5.2.1 General 5.2.2 Out of specification (OOS) investigation 5.2.3 Records |
| 19 | 5.2.4 Sample tracking 5.2.5 Integrity of results 5.2.6 Data recording 5.2.7 Data evaluation |
| 20 | 5.2.8 Trend analysis 6 Microbiological measurement methods 6.1 General 6.2 Choice of sampling method |
| 21 | 6.3 Volumetric air samplers 6.4 Culture media and incubation 6.5 Incubators |
| 22 | Annex A (informative)Guidance for life science pharmaceutical and biopharmaceutical applications A.1 Introduction |
| 23 | A.2 Risk/impact assessment A.3 Demonstrating control |
| 24 | Annex B (informative)Guidance for life science medical device applications B.1 Introduction B.2 Risk assessment B.2.1 General |
| 26 | B.2.2 Example 1: Sterile – terminal sterilisation is possible from a packaged product B.2.2.1 General B.2.2.2 Risk Assessment |
| 27 | B.2.2.3 Microbiological control method B.2.2.4 Suggested microbiological monitoring plan B.2.3 Example 2: Sterile – No terminal sterilisation is possible due to product properties B.2.3.1 General B.2.3.2 Risk assessment B.2.3.3 Microbiological control method B.2.3.4 Suggested monitoring plan B.2.4 Example 3: Non-sterile products B.2.4.1 General B.2.4.2 Risk assessment |
| 28 | B.2.4.3 Microbiological control method B.2.4.4 Suggested microbiological environmental monitoring (EM) plan B.3 Establishing Microbiological Control B.3.1 Microbiological contamination limits |
| 29 | B.3.2 Additional microbiological control considerations B.4 Demonstrating microbiological control B.4.1 Enumeration as part of measurement methods (Clause 6) B.4.2 Methods for sampling B.4.3 Microbiological Environmental Monitoring (EM) plan B.4.3.1 Number of measuring locations |
| 30 | B.4.3.2 Sampling frequencies for active air sampling B.4.3.3 Monitoring of personnel |
| 31 | B.5 Other informative annexes for Medical Device applications |
| 32 | Annex C (informative)Guidance for healthcare/hospital applications C.1 Introduction C.2 Establishing control in a healthcare/hospital application C.3 Risk assessment for operating room hospital applications |
| 33 | Annex D (informative)Guidance for food applications D.1 Introduction D.2 Establishment of microbiological control |
| 34 | D.3 Microbiological cleanliness levels for monitoring |
| 35 | D.4 Demonstration of microbiological control D.5 Example for food manufacture |
| 37 | Annex E (informative)Guidance on culture based microbiological measurement methods and sampler verification E.1 General E.2 Air sampling E.2.1 Volumetric air samplers E.2.1.1 General |
| 38 | E.2.1.2 Direct impaction air sampling E.2.1.3 Indirect impaction samplers |
| 39 | E.2.1.4 Remote air sampling E.2.2 Settle plates E.3 Surface sampling E.3.1 General E.3.2 Contact plates and strips |
| 40 | E.3.3 Swabs and sponges E.4 Microbiological growth media E.4.1 General E.4.2 Media suitability (media sterility and ability to support growth) |
| 41 | E.4.3 Media dehydration E.4.4 Media disinfectant inhibition E.4.5 Plate incubation E.5 Validation of air samplers E.5.1 General E.5.2 Physical collection efficiency |
| 42 | E.5.3 Biological collection efficiency E.6 Experimental method E.6.1 Aerosol chamber method E.6.1.1 General |
| 43 | E.6.1.2 Test strains of microorganisms E.6.1.3 Generation of microbe-carrying particles |
| 44 | E.6.1.4 Testing E.6.2 Simplified laboratory method E.6.2.1 General |
| 45 | E.6.2.2 Testing E.6.3 Incubation E.6.4 Collection efficiency calculations from testing results |
| 46 | E.6.5 Air sampler revalidation |
| 47 | Annex F (informative)Rapid microbiological methods (RMM) and alternative real time microbiological detection methods (AMMs) F.1 General F.2 Implementation of RMMs and AMMs |
| 48 | F.3 Validation of RMMs and AMMs F.3.1 General |
| 49 | F.3.2 Acceptance criteria considerations F.3.3 Verification test execution considerations F.4 Action and alert levels F.4.1 Setting action and alert levels F.4.2 Result outside of action and alert levels |
