Pharmacy Courses

Cleanliness Requirements of Primary Packaging Materials Manufacturing Facility

Pharmaceutical primary packaging is designed to provide protection from excessive transmission of moisture or solvents into or out of the product, provide light protection for the product, provide additional microbiological protection by protecting the product from microbial intrusion, and provide protection from excessive transmission of reactive gases. Examples of primary packaging include blister, vials, syringes, ampules, stoppers, closures, bottles, and pouches.

As per WHO,

Any area where pharmaceutical starting materials, products, primary packing materials, utensils and equipment are exposed to the environment should have the same level of cleanliness or classification as the area in which the products are produced.

Appropriate design and controls for the premises and HVAC systems should be in place to achieve containment, cleanliness and the appropriate levels of protection of the product, personnel and the environment.

So, cleanliness grade of primary packaging material manufacturing facility should be Class D or ISO Class 8 which are used for packaging of oral preparations. Such as, tablet, capsules.

But a lot of primary packaging manufacturers do not maintain Class D or ISO Class 8 during manufacturing of primary packaging material.

In this case, pharmaceutical companies should ensure primary packaging materials are purchasing from the manufacturers who ensure all applicable quality standards.

  • WHO Technical Report Series 1010, 2018; Annex 8

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