Pharmaceutical Packaging Rules and Regulations

Amy Hawthorne

by Amy Hawthorne

30th October 2014


As a consequence of the ongoing spread of diseases such as Ebola and hepatitis C, the pharmaceutical industry is seeing significant growth and to accompany the medicine, the pharmaceutical packaging market is also on the rise.

Pharmaceutical packaging has to be designed to prevent outside contaminates from entering the products, and it must be compatible with the substance it holds.

The forms that pharmaceutical packaging can take are varied; ampoules, syringes, blister packs, medicine bottles, nasal spray and ointment. All of these types of medicinal packaging (and more) have to undergo strict testing and processes to ensure they conform to the rules and standards of the pharmaceutical industry. If they fail, they won’t make it onto the chemists’ shelves.

Strict Standards

Rules, regulations and international standards

It’s essential that pharmaceutical packaging is manufactured in a suitable environment, using the appropriate processes to prevent contaminates from entering the pharmaceutical product. Pharmaceuticals have to be of a particularly high quality, and the same is true for pharmaceutical packaging.

The packaging has to conform to pharmacopoeia standards. For example, water used in processes should be EP grade which ensures it is low in impurities and meets worldwide specifications.

Ingredients must comply with EU standards and should undergo strict quality control. Often, small samples are manufactured for pre-production testing in order to test both the contents and the suitability and conformity of the packaging.

A proper location for pharmaceutical processes

To ensure products remain free from contamination, the packaging and re-packaging of pharmaceutical products should be carried out in a cleanroom.

A cleanroom is a useful area for packing pharmaceutical products. It acts as a place to handle products that are sensitive to contamination as it reduces particles in the air and keeps the product pure.

ReAgent’s class 7 cleanroom provides us with an area of a known air quality. We can carry out critical processes and our customers can be assured that their products have undergone controlled processes and regulations have been adhered to.

Safe Pharmaceutical Packaging

Child safety caps


Children’s medicine bottles come with a child safety cap to deter children from using it without adult supervision

Children’s medicine may come in a tasty strawberry flavour, with appealing bottle designs showing pictures of teddy bears and Disney princesses, but it is also designed to stop children using it in a dangerous manner.

Child safety caps are an effective child-resistant feature on medicine bottles, which undergo significant testing before they reach the market. This important safety measure makes it difficult for children to gain access to the contents, so they can’t consume the medicine in uncontrolled amounts.

Pharmaceutical packaging for children undergoes performance tests to determine that they are too difficult for most children to open. This is an international regulation.

Child-resistant pharmaceutical packaging must comply with ISO 8317 – the standard that explains the test methods for caps such as those on bleach and medicine bottles. Testing guidelines state that a child-resistant pack or bottle should be impossible to open for at least 85% of children in the first five minutes.

Deterring children from unsafe pharmaceutical products

Products such as children’s vitamins may seem harmless, but consuming more than advised can be harmful to a child.

These vitamins, as well as tablets designed for adults, are often packaged in blister packs. To improve child safety, these packs may have an extra function so children cannot easily open them, such as being made of a strong material that is difficult to peel off.

MHRA states that medicines containing aspirin, paracetamol and more than 24mg of elemental iron must be contained in pharmaceutical packaging that has been proven to be child-resistant. This measure is in place to prevent the accidental poisoning of young children.

Pharmaceutical Packaging Techniques

Heat-sealing technique

Using heat to seal packets is a common technique in pharmaceutical packaging. Hermetically-sealing containers helps to ensure that impurities are kept outside and don’t contaminate the product, which is vital when packaging pharmaceutical items.

At ReAgent, we use a Rota 915 ampoule filling machine that allows us to fill ampoules with any non-flammable liquid compatible with glass. We use an open flame to seal the ampoules and protect the product from airborne contaminates.

An ampoule may be used as a prototype for pharmaceutical products. The small sample is ideal for testing before the medicine is scaled up to full-size manufacture.

Polyethylene printing

Polyethylene (PE) is generally the material chosen for the labels on pharmaceutical packaging.

Manufacturers may use Laserprint PE which describes durable and highly adhesive labels used in pharmaceutical and other chemical applications. The print on these labels must adhere to the BS 5609 standard to ensure they are durable enough to be fully legible for at least three months of being immersed in sea water.

This is an important health and safety measure as the labels describe any threats to people or the environment that the product may present, so anyone handling the product can take the correct precautions.

With such a prominent role across the globe, it’s important that medical products are manufactured and packed in alliance with the correct guidelines and standards. For more information about our pharmaceutical services, please contact our sales team.

A page will be uploaded shortly to our website regarding pharmaceutical services at ReAgent.


All content published on the blog is for information only. The blog, its authors, and affiliates cannot be held responsible for any accident, injury or damage caused in part or directly from using the information provided. Additionally, we do not recommend using any chemical without reading the Material Safety Data Sheet (MSDS), which can be obtained from the manufacturer. You should also follow any safety advice and precautions listed on the product label. If you have health and safety related questions, visit

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