AS 1952-1986

1 - AS 1952-1986 DISPENSING MEASURES - PHARMACEUTICAL - GLASS
4 - PREFACE
5 - CONTENTS
6 - 1 SCOPE.
6 - 2 APPLICATION.
6 - 3 REFERENCED DOCUMENTS.
6 - 4 DEFINITIONS.
6 - 4.1 Capacity corresponding to any scale mark
6 - 4.2 Permanently marked
6 - 5 MATERIAL.
6 - 6 DESIGN.
6 - 6.1 General.
6 - 6.2 Cone angle.
6 - 6.3 Pouring lip.
6 - 6.4 Bottom of measuring space.
6 - 7 CONSTRUCTION.
6 - 7.1 General.
8 - 7.2 Total capacity.
8 - 7.3 Base.
8 - 8 MARKINGS.
8 - 8.1 Scale markings.
9 - 8.2 Other markings.
9 - 9 PERFORMANCE REQUIREMENTS.
9 - 9.1 Introduction.
10 - 9.2 Sequence for conducting tests.
10 - 9.3 Resistance of packaged measure to mechanical
10 - 9.4 Freedom from strain.
10 - 9.5 Resistance to leaching.
10 - 9.6 Transparency.
10 - 9.7 Accuracy of calibration.
10 - 9.8 Thermal shock resistance.
10 - 9.9 Stability.
10 - 9.10 Permanence of markings.
11 - 10 SELECTION OF SPECIMENS FOR TYPE
11 - 11 PACKAGING.
12 - APPENDIX A - METHOD FOR ASSESSING RESISTANCE OF PACKAGED GLASS PHARMACEUTICAL MEASURE( S) TO MECHANICAL SHOCK
12 - A1 SCOPE.
12 - A2 CONDITIONS OF TEST.
12 - A3 PROCEDURE.
12 - A4 REPORT.
13 - APPENDIX B - DETECTION OF STRAIN IN GLASS USING A SIMPLE POLARISCOPE
13 - B1 SCOPE.
13 - B2 APPARATUS.
13 - B2.1 A polariscope.
13 - B2.2 Polarizing sunglasses.
13 - B3 PROCEDURE.
13 - B4 GUIDELINES FOR ASSESSING THE PRESENCE OF STRAIN.
14 - B5 REPORT.
16 - APPENDIX C - DETERMINATION OF RESISTANCE TO LEACHING
16 - C1 SCOPE.
16 - C2 PRINCIPLE.
16 - C3 REAGENTS.
16 - C3.1 Introduction.
16 - C3.2 General solutions.
16 - C3.3 Standard lead solutions.
16 - C4 APPARATUS AND SPECIAL ENVIRONMENTS.
16 - C4.1 Constant temperature zone.
17 - C4.2 Nessler cylinders.
17 - C5 PROCEDURE.
17 - C6 REPORT.
18 - APPENDIX D - METHOD FOR ASSESSING TRANSPARENCY
18 - D1 SCOPE.
18 - D2 GENERAL.
18 - D3 TEST SITE AND LIGHT SOURCE.
18 - D4 SURFACE COLOUR OF BACKGROUND AND BENCH.
18 - D5 TEST LIQUIDS.
18 - D5.1 Distilled or demineralized water.
18 - D5.2 Fresh, homogenized milk.
18 - D5.3 ‘Instant’ coffee in distilled water (10 g/ L),
19 - D6 PROCEDURE.
19 - D7 REPORT.
20 - APPENDIX E - DETERMINATION OF ACCURACY OF CALIBRATION
20 - E1 SCOPE.
20 - E2 PROCEDURE.
20 - E3 REPORT.
21 - APPENDIX F - METHOD FOR ASSESSING RESISTANCE TO THERMAL SHOCK
21 - F1 SCOPE.
21 - F2 APPARATUS.
21 - F2.1 Stopwatch
21 - F2.2 Boiling water bath
21 - F2.3 Water bath
21 - F2.4 Pair of long-handled tongs
21 - F3 PROCEDURE.
21 - F4 REPORT.
22 - APPENDIX G - METHOD FOR ASSESSING PERMANENCE OF MARKINGS
22 - G1 SCOPE.
22 - G2 PRINCIPLE.
22 - G3 REAGENTS.
22 - G4 APPARATUS.
22 - G4.1 Constant temperature environment.
22 - G4.2 Test bath(s) / container(s).
23 - G43 Control measure(s).
23 - G5 TEST PLAN.
23 - G5.1 Preliminary considerations.
23 - G5.2 Choice of plan.
23 - G6 PROCEDURE.
24 - G7 REPORT.
25 - APPENDIX H - DETERMINATION OF COMPLIANCE OF A LOT, BATCH, CONSIGNMENT, ETC
25 - H1 AUSTRALIAN STANDARDSMARK.
25 - H2 ASSESSMENT OF COMPLIANCE ON THE BASIS OF STATISTICAL SAMPLING
25 - H3 ASSURANCE OF COMPLIANCE ON THE BASIS OF SUPPLIERS QUALITY CONTROL SYSTEMS
25 - H4 SAMPLING FREQUENCY BY AGREEMENT.

Specifies essential requirements for glass conical and glass beaker dispensing measures used for pharmaceutical purposes. Provides description of performance tests for checking specifications and for assessing suitability of the measures for AS marking, including detection of strain, resistance to leaching, accuracy of calibration, resistance to thermal shock and resistance to mechanical shock (of packaged measure).

This standard specifies essential requirements for glass conical dispensing measures of capacities 5, 10, 20, 50, 100 and 200 mL and glass beaker dispensing measures of capacities 500 and 1000 mL for pharmaceutical purposes.

Reconfirmed 1995