November 19, 2018

3 Quality Control Tests You Cannot Afford to Skip for Your Healthcare Product Packaging

There is only one way to ensure your product packaging is effective:

Take the quality of your packaging as seriously as you take the quality of your product.

The packaging of your healthcare or pharmaceutical CPG product affects the stability, protection, presentation and convenience of your product from the moment it leaves your warehouse.

This applies to your secondary packaging as much as it applies as your primary packaging.

So much emphasis is put on primary packaging quality — and for good reason — but don’t make the mistake of leaving your secondary packaging as an afterthought.

That secondary packaging makes all the difference in the presentation of your product on store shelves, the clarity and accessibility of critical information about the product, and even creating a more convenient experience for consumers that encourages them to follow their healthcare practitioner’s advice. At we talk about cbd oils, and how important it is that the person follows it’s instructions carefully. Many medications can be dangerous if not taken as prescribed, and a person can always forget what instructions were issued to him or her (courses like apprise medical practitioners on what’s harmful before they graduate to become prescriptionists). Clear packaging that clearly states any important instructions can avoid many health issues that would in fact be more detrimental to the patients health that not having done anything at all.

In the healthcare CPG product industry, quality assurance is a critical component of Good Manufacturing Practice (GMP). Quality consistency demands thoughtful packaging design, comprehensive quality control testing procedures, and using licensed and audited suppliers. While there are quality assurance testing procedures required for every country in which you intend to sell your product, there are three specific areas where some packaging operations are falling short. Taking testing more seriously in these three areas will keep your consumers safer — and better guarantee placement for your product on store shelves.

1. Test, Test and Double Test

The conditions your packaging are exposed to will affect the physical and chemical characteristics of the materials they’re made from. Poorly chosen materials may result in holes or thinning, or even wearing down of the coating of your packaging, resulting in loss of structural integrity or destruction of critical consumer-facing information.

Even for secondary packaging, materials must also be compatible and withstand the forming, sealing and handling processes, it is a must to use services like the ones offered at when thinking about packaging.

The three quality control areas to concentrate on for your materials tests are:

  1. Chemical: Check the pH value of the materials. Measure the chloride and sulphate in the paper or board. Analyze the alkalinity of glass. Then with those results, run compatibility tests with the chemicals and conditions that the packaging may encounter.
  2. Physical / Mechanical: Study the effect of creasing, folding and tearing of the materials to catch any potential problems before they occur once packaging is produced.
  3. Environmental: Consider what environmental conditions the material may be impacted by. How does it respond to different temperatures, levels of light, absorption of water, or exposure to water vapour, gases or odours?
Healthcare Package Inspection Check

2. Check the Quality of Your Packaging Construction

The nature of the product, the planned sterilisation process, how the packaging is intended to be used, the expiration date of the product, and the transport and storage of the package will directly affect how your packaging should be constructed.

Testing your packaging integrity will alert you to any possible issues that may come up around environmental conditions or stresses the packaging is subject to once it leaves your warehouse.

The two quality control areas to concentrate on for your packaging construction tests are:

  1. Structural / Mechanical: Your packaging should protect your product from transportation hazards. Test the packaging to make sure it will withstand the trip from the warehouse to store shelves (we always complete shipping and durability tests with our packaging and display designs).
  2. Environmental: What environments will your product be exposed to? Make sure the packaging can withstand elements such as heat, cold, moisture and light.

For pharmaceutical products, maintaining sterility is also an important concern. Your packaging must be tested to provide physical protection and keep the product sterilized until the packaging is opened.

Pharmatutor provides a list of ideal requirements of a good package, and we think it’s a great reference to have on hand (though we’ve adjusted the language a bit to be clearer):

  • It should be able to protect the product without loss on account of leakage, spoilage or permeation.
  • It should protect against environmental conditions like light, air and moisture during transportation and storage.
  • It should not be permeable to gases.
  • It should possess sufficient strength to withstand the shock of handling, loading, transportation,etc.
  • It should facilitate the efficient, safe and convenient use of the product.
  • The material should not interact with the contents.
  • It should protect the product from moulds, bacteria and other contaminants.
  • The cost of material should be as low as possible without compromising the quality of the packaging.
  • It should facilitate easy identification of the product.
  • The closure should be airtight.
  • The closure should be compatible with the planned preparation.

3. Don’t Skip the Label Check

The accuracy and physical stability of labels in healthcare and pharmaceutical packaging is often under-checked — yet errors are often reported.

An important quality control test you should be doing here is ensuring the label on the secondary packaging matches the label on the primary packaging. A mistake with this can cost you in lost shelf placement and repackaging fees. But more importantly, it can pose a serious safety risk to consumers. The second important quality control test is around the integrity of the labels. Are they legible and non-transferring? Do they remain intact after handling, transport and storage? Once again, if the labels don’t hold up to normal shipping and use, it can cost you in fees and risk consumer safety.

Don’t stop there: Follow the WorldHealth Organization Guidelines and ISO 11607

Quality control is not confined to laboratory operations but must be involved in all decisions concerning the quality of the product.

— WHO Expert Committee on Specifications for Pharmaceutical Preparations in the WHO Technical Report Series, No. 823.

The World Health Organization (WHO) lays out these guidelines on packaging for pharmaceutical products to meet GMP standards (these are taken directly from their Guidelines on Packaging for Pharmaceutical Products document):

  1. Adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting and testing starting materials, packaging materials, and intermediate, bulk and finished products, and where appropriate for monitoring environmental conditions for GMP purposes.
  2. Samples of starting materials, packaging materials, intermediate products, bulk products and finished products must be taken by methods and personnel approved of by the quality control department.
  3. Test methods must be validated.
  4. Records must be made (manually and/or by recording instruments) demonstrating that all the required sampling, inspecting and testing procedures have actually been carried out and that any deviations have been fully recorded and investigated.
  5. The finished products must contain ingredients complying with the qualitative and quantitative composition of the product described in the marketing authorization; the ingredients must be of the required purity, in their proper container, and correctly labelled.
  6. Records must be made of the results of inspecting and testing materials and intermediate, bulk and finished products against specifications; product assessment must include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures.

In addition to those guidelines, the most recognized packaging standards are found in:
ISO 11607-1: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems 

and ISO 11607-2: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes.

The Best Thing You Can Do to Ensure Your Packaging Quality is Assured

Our GMP complaint clean room in Markham, ON. Canada

Of course, the best thing you can do to ensure quality control for your packaging is to work with a contract packager that is fully compliant and regularly audited. Bonus points if they meet the highest security standards and have a GMP-compliant clean room.

If you’re preparing to sell your healthcare or pharmaceutical CPG product in Canada, and you’re looking for a co-packer that meets those requirements — that co-packager is Ravenshoe Group. I can attest to how critical quality control is when it comes to your packaging. Get in touch with Ravenshoe Group todayI’d love to talk to you about how we ensure your compliance and your consumers’ safety here in Canada.

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