IS 19084 : 2024 Plastic Containers and Closures for Homoeopathic Pharmaceutical Preparations - Specification
1 SCOPE
This standard prescribes the materials, requirements, sampling methods and testing of plastic containers (phials, bottles and jars) and closures (screw caps, droppers and stoppers) used for storing and dispensing different dosage forms in homoeopathy.
This document is applicable to Phials, Jars, Dropdispensing and Screw-neck plastic bottles for liquid and solid preparations used in Homoeopathy. Together with the corresponding closure systems, they are used for packaging and dispensing of homoeopathic pharmaceutical preparations in solid and liquid dosage forms.
2 REFERENCES
The standards listed in Annex A contain provisions which, through reference in this text, constitute provisions of this standard. At the time of publication, the editions indicated were valid. All standards are subject to revision and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent edition of these standards.
| IS No. | Title |
| IS 2798 : 1998 | Methods of test for plastics containers (first revision) |
| IS 2828 : 2019/ISO 472 : 2013 | Plastics - Vocabulary (second revision) |
| IS 4905 : 2015/ISO 24153 : 2009 | Random sampling and randomization procedures (first revision) |
| IS 7019 : 1998 | Glossary of terms in plastics and flexible packaging, excluding paper (second revision) |
| IS 7328 : 2020 | Specification for polyethylene material for moulding and extrusion (third revision) |
| IS 7803 (Part 1) : 1975 | Specification for plastic containers for pharmaceutical use: Part 1 Other than parenteral and ophthalmic preparations |
| IS 8747 : 1977 | Methods of test for environmental stress-crack resistance of blow-moulded polyethylene containers |
| IS 9833 : 2018 | List of colourants for use in plastics in contact with foodstuffs and pharmaceuticals (second revision) |
| IS 9845 : 1998 | Determination of overall migration of constituents of plastics materials and articles intended to come in contact with foodstuffs - Method of analysis (second revision) |
| IS 10951 : 2020 | Specification for polypropylene (PP) materials for moulding and extrusion (second revision) |
| IS 12252 : 2017 | Polyalkylene terephthalates (PET and PBT), their copolymers and list of constituents in raw materials and end products for their safe use in contact with foodstuffs and pharmaceuticals (first revision) |
| IS 14534 : 2023 | Plastics - Recovery and recycling of plastics waste - Guidelines (second revision) |
| IS 15410 : 2003 | Containers for packaging of natural mineral water and packaged drinking water - Specification |
| IS 83761 : 8181 | Positive list of constituents for polypropylene, polyethylene and their copolymers for its safe use in contact with foodstuffs and pharmaceuticals |