Foreword

Introduction

1Scope

2Normative references

3Terms and definitions

4General requirements

4.1Quality systems

4.2Testing

4.3Documentation

5Syringe barrel

5.1Design including dimensions

5.1.1Dimensions for 6 % Luer slip and 6 % Luer slip for Luer lock adapter front end syringes

5.1.2Specific dimensions for front end design for 6 % Luer slip and 6 % Luer slip for Luer lock adapter

5.1.3Dimensions for staked needle (SN) syringes

5.1.4Front end design for staked needle syringe

5.2Functional testing of Luer connection

5.3Material

5.4Performance requirements

5.4.1Hydrolytic resistance glass barrel

5.4.2Annealing quality

5.4.3Lubrication of the inner surface

5.4.4Flange breakage resistance

5.4.5Front end breakage resistance

6Sterilized subassembled syringes ready for filling

6.1General

6.1.1Design

6.1.2Raw materials properties

6.1.3Documentation

6.2Sterility

6.3Pyrogenicity/endotoxins

6.4Particulate matter

6.5Additional requirements to specific components of sterilized subassembled syringes ready for filling

6.5.1Syringe barrel

6.5.1.1General

6.5.1.2Lubricated syringes

6.5.1.3Lubrication-free syringes

6.5.1.4Dead space

6.5.2Needle

6.5.2.1General

6.5.2.2Material and dimension

6.5.2.3Surface treatment

6.5.2.4Penetration force

6.5.2.5Needle lumen patency

6.5.2.6Needle bonding and bonding strength

6.5.3Syringe closure system

6.5.3.1Design

6.5.3.2Materials

6.5.3.3Sterilization

6.5.3.4Liquid leakage

6.5.3.5Luer connectors/Luer lock adapters

6.5.3.6Unscrewing and pull-off forces

6.6Syringe closure system tightness

7Packaging

8Labelling

Annex AExamples of types of sterilized subassembled syringes ready for filling (informative)

A.1Components

A.2Description of front end syringe closure systems

A.2.1General

A.2.2Closures for syringes with 6 % Luer slip

A.2.3Closures for syringes with 6 % Luer slip for Luer connectors

A.2.4Closures for syringes with staked needle

Annex BAdditional components for a subassembled syringe ready for filling (informative)

Annex CTest methods for syringe barrels (normative)

C.1Flange breakage resistance

C.1.1Principle

C.1.2Materials

C.1.3Apparatus

C.1.4Preparation and preservation of test samples

C.1.5Procedure

C.1.6Expression of results

C.1.7Test report or documentation

C.2Front end breakage resistance

C.2.1Principle

C.2.2Materials

C.2.3Apparatus

C.2.4Procedure

C.2.5Expression of results

C.2.6Test report or documentation

Annex DSample preparation for endotoxin and particulate determination (informative)

D.1Endotoxins

D.1.1General

D.1.2Materials and equipment

D.1.3Procedure

D.2Particulates

D.2.1General

D.2.2Materials and equipment

D.2.3Procedure

Annex EGlide force test method (informative)

E.1Purpose

E.2Materials

E.3Apparatus

E.4Procedure

E.5Test report or documentation

Annex FNeedle penetration test (informative)

F.1Principle

F.2Apparatus

F.3Materials

F.4Procedure

F.5Test report or documentation

Annex GTest methods for front end components (normative)

G.1Needle pull-out force

G.1.1Principle

G.1.2Materials

G.1.3Apparatus

G.1.4Preparation and preservation of test samples

G.1.5Procedure

G.1.6Expression of results

G.1.7Test report or documentation

G.2Syringe closure system liquid leakage test

G.2.1Principle

G.2.2Reagents and materials

G.2.3Apparatus

G.2.4Preparation and preservation of test samples

G.2.5Procedure

G.2.6Expression of results

G.2.7Test report or documentation

G.3Luer lock adaptor collar pull-off force

G.3.1Principle

G.3.2Materials

G.3.3Apparatus

G.3.4Preparation and preservation of test samples

G.3.5Procedure

G.3.6Expression of results

G.3.7Test report or documentation

G.4Luer lock adaptor collar torque resistance

G.4.1Principle

G.4.2Materials

G.4.3Apparatus

G.4.4Preparation and preservation of test samples and test pieces

G.4.5Procedure

G.4.6Expression of results

G.4.7Test report or documentation

G.5Luer lock rigid tip cap unscrewing torque

G.5.1Principle

G.5.2Materials

G.5.3Apparatus

G.5.4Preparation and preservation of test samples and test pieces

G.5.5Procedure

G.5.6Expression of results

G.5.7Test report or documentation

G.6Pull-off force of the tip cap or the needle shield

G.6.1Method 1

G.6.1.1Principle

G.6.1.2Materials

G.6.1.3Apparatus

G.6.1.4Procedure

G.6.1.5Expression of results

G.6.1.6Test report or documentation

G.6.2Method 2

G.6.2.1Principle

G.6.2.2Materials

G.6.2.3Apparatus

G.6.2.4Procedure

G.6.2.5Expression of results

G.6.2.6Test report or documentation

Annex HTightness test (informative)

H.1General

H.2Principle

H.3Apparatus, equipment and reagents

H.4Preparation and preservation of test samples and test pieces

H.5Procedure

H.6Test report or documentation

Bibliography