ДСТУ EN 17141:2022 Чистые помещения и соответствующая контролируемая среда. Контроль биозагрязнения (EN 17141:2020, IDT)



ДСТУ EN 17141:2022
(EN 17141:2020, IDT)

Чисті приміщення та відповідне контрольоване середовище. Контроль біозабруднення

 
   
 
 
     
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

European foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Establishment of microbiological control

4.1 General

4.2 Establishing a formal system for microbiological control

4.3 Microbiological contamination control system quality attributes

4.4 Identification of all potential sources and routes of microbiological contamination

4.4.1 General

4.4.2 Sources of microbiological contamination

4.4.3 Routes of transfer of microbiological contamination

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

4.7 Establishment of alert and action limits

4.8 Establishment of documentation system

4.9 Personnel education and training

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

5.2.4 Sample tracking

5.2.5 Integrity of results

5.2.6 Data recording

5.2.7 Data evaluation

5.2.8 Trend analysis

6 Microbiological measurement methods

6.1 General

6.2 Choice of sampling method

6.3 Volumetric air samplers

6.4 Culture media and incubation

6.5 Incubators

Annex A (informative) Guidance for life science pharmaceutical and biopharmaceutical applications

A.1 Introduction

A.2 Risk/impact assessment

A.3 Demonstrating control

Annex B (informative) Guidance for life science medical device applications

B.1 Introduction

B.2 Risk assessment

B.2.1 General

B.2.2 Example 1: Sterile - terminal sterilisation is possible from a packaged product

B.2.3 Example 2: Sterile - No terminal sterilisation is possible due to product properties

B.2.4 Example 3: Non-sterile products

B.3 Establishing Microbiological Control

B.3.1 Microbiological contamination limits

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.5 Other informative annexes for Medical Device applications

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

Annex D (informative) Guidance for food applications

D.1 Introduction

D.2 Establishment of microbiological control

D.3 Microbiological cleanliness levels for monitoring

D.4 Demonstration of microbiological control

D.5 Example for food manufacture

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.2.2 Settle plates

E.3 Surface sampling

E.3.1 General

E.3.2 Contact plates and strips

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)

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

E.5.3 Biological collection efficiency

E.6 Experimental method

E.6.1 Aerosol chamber method

E.6.2 Simplified laboratory method

E.6.3 Incubation

E.6.4 Collection efficiency calculations from testing results

E.6.5 Air sampler revalidation

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

F.3 Validation of RMMs and AMMs

F.3.1 General

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

Bibliography