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Rubber Closures and Secondary Packaging

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Department of Pharmaceutical Sciences and Technology

Birla Institute of Technology, Mesra Ranchi- 835215 (Jharkhand)

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Learning Objectives

  • Role of Rubber Closures
  • Polymers used in the rubber closures
  • Quality control test for rubber closures
  • Secondary Packaging

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Introduction

  • Rubber is a material that is used in the pharmaceutical business to create dropper assemblies, cap liners, and closures.
  • The rubber stopper is mostly utilized with disposable syringes and numerous dosage vials.
  • Aqueous parenteral bottle closures made of rubber powder and freeze-dried powder preparations.

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Polymers used in Rubber Closures

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The basic types of polymers in rubber formulations are saturated and unsaturated elastomers or a combination of the two. The following classification lists of the polymers utilized as parenteral closures.

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Unsaturated elastomers:

  • Polyisoprene- natural or synthetic
  • Polybutadiene
  • Styrene butadiene rubber
  • Nitrile butadiene rubber
  • Polychloroprene

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Saturated Elastomers�

  • Copolymer of polyisobutylene and polyisoprene (butyl)
  • Ethylene propylene rubber
  • Ethylene propylenediene rubber
  • Silicone rubber

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Quality control test for rubber closures

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Sterility Testing

  • A test known as a sterility test verifies that a product is free of the existence of living microorganisms.
  • These tests can reveal whether a pharmaceutical product or device contains viable types of bacteria, fungi, or yeast.

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Fragmentation Test�

  • By puncturing the rubber closure with a hypodermic syringe
  • The Fragmentation Tests are used to compare the number of fragments discovered in water with that of another rubber closure.

Fragmentation tests for Rubber closure:

  • Take 12 clean containers each should have 4ml of water in them
  • For 16 hours, seal the container with a closure and caps. Apply a hypodermic needle to the cap to pierce it
  • For each closing, repeat the process four times and note how many fragments are evident on the rubber closures

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���Take a pause� �

  • What do you mean by Rubber Closure?
  • What are the QC tests for the rubber closures?

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Fragmentation Test for Dry Preparation

  • Self seal Ability
  • pH of aqueous extract
  • Light absorption test
  • Reducing substances
  • Residue on evaporation

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Secondary Packaging

  • The packaging that is located outside of the primary packing is referred to as secondary packaging. Perhaps primary packages are grouped together using it. For instance: Paper and boards, Cartons, boards, cartons, corrugated fibers, and box manufacturing.

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Secondary packaging

Primary Packaging

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Ideal Properties of Secondary Packaging Material�

  • To bear the strain during shipping, the dimensions must be suitable
  • It shouldn't have an impact on the basic packing
  • It should be strong enough to support the material
  • The dimensions should be appropriate to withstand the stress during the transportation

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�������Prepared By�Arbaz Karim ��Pharmaceutical Quality Assurance��

Department of Pharmaceutical Sciences & Technology�Birla Institute of Technology Mesra, �Ranchi