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.