Requirements for Pharmaceutical dosage form containers

Every pharmaceutical preparation must comply with the labeling requirements laid down in the WHO guidelines on GMP for pharmaceutical products.

Tablets. 

These should be kept in well-closed containers and protected from light, moisture, crushing and mechanical shock. Any special storage conditions should be stated on the label. Tablets should be able to withstand handling, including packaging and transportation, without losing their integrity. Moisture-sensitive forms, such as effervescent tablets, should be stored in tightly closed containers or moisture-proof packs, and may require the use of separate packages containing water-adsorbent agents, such as silica gel. Additional special recommendations for packaging, storage and transportation are specified in the relevant individual monographs. For effervescent tablets, the label should state “Not to be swallowed directly”.

Capsules.

These should be packaged and stored in a manner that protects them from microbial contamination. Capsules should be kept in well-closed containers. They should be protected from light, excessive moisture, or dryness, and should not be subjected to temperatures above 30°C. Additional special recommendations for packaging, storage and transportation are specified in the relevant individual monographs.

Parenteral preparations.

These are usually supplied in glass ampoules, bottles or vials, plastic bottles or bags, and prefilled syringes, which are colored in the case of light-sensitive substances. Except where otherwise indicated in the relevant individual monographs, the containers for parenteral preparations should be made from a material that is sufficiently transparent to permit the visual inspection of the contents. They should not adversely affect the quality of the preparation, allow diffusion of any kind into or across the container, or release foreign substances into the preparation. Closures for containers for parenteral preparations should be equipped with a firm seal to prevent the entry of microorganisms and other contaminants while permitting the withdrawal of a part or the whole of the contents without removal of the closure. They should not be made of materials that react with the contents, nor should they allow foreign substances to diffuse into the preparation. The elastomers of which the closure is made should be sufficiently firm to allow the passage of a needle with the least possible shedding of particles. Closures for multi-dose containers should be sufficiently elastic to allow the puncture to reseal when the needle is withdrawn and thus protect the contents from airborne contamination. On visual inspection, solutions, reconstituted solutions and intravenous infusions (except dispersions) should be clear and free from visible particulate matter.

Topical semi-solid dosage forms.

Containers for these dosage forms should be made from a material that does not adversely affect the quality of the preparation or allow diffusion of any kind into or across the container into the preparation. Closures for these containers should be of a design that minimizes microbial contamination and be equipped with a device that reveals whether the container has ever been opened. Containers for topical semi-solid dosage forms should protect the preparation from light, moisture, and damage during handling and transportation. The use of suitable metal or plastic flexible tubes is preferred. Preparations for nasal, aural, vaginal or rectal use should be supplied in containers adapted for the appropriate delivery of the product to the site of application, or should be supplied with a suitable applicator. Topical semi-solid dosage forms should be kept in well-closed containers. The preparation should maintain its pharmaceutical integrity throughout the shelf-life when stored at the temperature indicated on the label; this should normally not exceed 25 °C. Special storage recommendations or limitations are indicated in the relevant individual monographs.