Pharmaceutical Packaging Rules & Regulations

Lucy Bell-Young

by Lucy Bell-Young

4th November 2020

The rules and regulations for pharmaceutical packaging have been designed to prevent outside contaminants from entering the products. According to these standards, packaging for pharmaceuticals must also be compatible with the substance it holds.

The forms that pharmaceutical packaging can take vary from ampoules, syringes, and blister packs, to medicine bottles, nasal sprays, and ointments. All of these types of medicinal packaging have to undergo strict testing and processes to ensure they conform to the rules and regulations of the pharmaceutical industry. If they fail, they won’t make it onto the chemists’ shelves.

Pharmaceutical Packaging Standards

Rules, Regulations And International Standards

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

  • Packaging for pharmaceuticals has to conform to pharmacopoeia standards. For example, water used in processes should be EP grade, which ensures that it’s 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, as well as 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 able to effectively remove airborne contaminants, like dust, by using filters to purify any air that gets inside. This makes it an ideal place to handle products that are sensitive to contamination as it reduces particles in the air and keeps the products pure.

The cleanroom in ReAgent’s manufacturing premises provides us with an area of known air quality. Here, we can carry out critical processes, and our customers can be assured that their products have undergone controlled processes and that regulations have been adhered to.

Scientist in sterile overalls in cleanroom packaging pharmaceuticals

To ensure products remain contaminant-free, the packaging and re-packaging of pharmaceuticals should be carried out in a cleanroom

Pharmaceutical Packaging Labels

The labels used on pharmaceutical packaging must also follow their own set of rules and regulations. Correctly labelling pharmaceutical packages is important because:

  • It ensures that all users have a clear understanding of what they’re taking
  • It ensures that all users understand how to safely consume the medicine and at what dose
  • It ensures that any side effects or warnings are clearly visible to users

The safe consumption of pharmaceutical products ultimately depends on how well the user understands the label, and how accurate the label is at explaining things like dosage, warnings, ingredients, side effects, storage recommendations, and much more. Another important thing to consider with pharmaceutical packaging labels is how they have been formatted. For example, information on packaging labels must be clear, visible, and easy to understand.

There are a lot of best practices to consider when labelling pharmaceuticals, including:

  • Naming the product clearly and unambiguously
  • Providing clear instructions on how to administer the product
  • Clearly outlining posology and any associated risks
  • Including all the relevant CLP hazard symbols

Safe Pharmaceutical Packaging

Materials Used In Pharmaceutical Packaging

The materials used in pharmaceutical packaging are crucial for ensuring that the product remains free of contaminants. The type of material used depends on which category of pharmaceutical packaging is required:

  • Primary packaging is used when the drug comes into direct contact with the container, such as with ampoules, syringes, sachets, blister packs, and most other types of containers. For this reason, primary packaging should be inert so that it doesn’t react with the product inside. Common types of materials used for primary pharmaceutical packaging include glass, thermoformed plastic, and stainless steel.
  • Secondary packaging is used when the product has not and will not come into direct contact with the container. This includes things like cardboard boxes and cartons. The type of material used in secondary packaging for pharmaceuticals is less important since there will be no chance of it contaminating the product.
  • Tertiary packaging is used in factories to protect the product during storage or transit. It’s rarely ever seen by the consumer, and also doesn’t come into contact with the contained product. Examples of tertiary pharmaceutical packaging include wooden pellets, shrink wrap, and cardboard or plastic boxes. Whatever the material, it should provide ample protection against things like light or temperature. For example, if a product is sensitive to heat or sunlight, opaque HDPE containers should be used.

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.

Medical ampoules close up

Ampoules are hermetically-sealed containers that prevent contaminants from reaching the product inside

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.

Importance of Pharmaceutical Packaging

In short, following the rules and regulations for pharmaceutical packaging is important for a number of reasons:

  • It ensures that the product is safe for consumption and free of contaminants
  • It maintains the quality and efficacy of the medicine inside
  • It provides clear information to users about how the product should be taken or stored

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.


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