Pharmaceutical Packaging: The Last Line of Defense

What’s on the outside matters too.

Outside of the medical field it is easy to take the “small stuff” for granted. In most countries, people are fortunate enough to have the ability to bring a prescription to a pharmacy and get the medicine they need. This is a very straightforward transaction. Typically, you get the prescription, read the label, tear into that box/bottle/vial, and feel better in a few days. While it may seem easy-peasy, there were plenty of unseen obstacles coming between you and that medicine.

Pharmaceutical Packaging Types

1. Primary packaging: Any material that comes in direct contact with the product. There are plenty of options here including vials, bottles, syringes, stoppers, blister packs, etc.
2. Secondary packaging: Additional packaging that will contain the important medication information, like the ingredients and instructions, but never touches the product itself. A good example would be the box holding the blister pack.
3. Tertiary Packaging: This packaging is invisible to the end-user and protects the goods during the shipping process. It is essentially packaging to protect the packaging.

While this may seem like a bit of overkill, it’s truly the only option. Producing medication is a very sophisticated chemical balance and is significantly affected by environmental factors like shape, size, temperature, etc. For example, the CDC prepared a thorough storage and handling summary regarding primary packaging to ensure the COVID-19 vaccine remains effective. It should come as no surprise that packaging manufacturers must undergo strict compliance requirements and acquire approval from agencies such as the FDA, EMA, etc.

How Pharmaceutical Packaging can go Wrong

Think of the containers, receptacles, and distribution devices as the final line of protection. They ensure:

• • Contamination does not enter the medication/human body.
  • The contents will not be altered.
  • The required dose will be administered.
  • The individual handling the medication is protected and can do so safely.

1) Material Imperfections

It is not simply the material that houses the vaccine or medicine that can affect the make-up of the fluid but the state of it. Before vials can be filled, the glass and stoppers/crimps/plungers must be 100% inspected for dust, foreign particles, dents, scratches, cracks, defects, discoloration, and shape perfection. Any of these factors can affect the integrity of the pharmaceutical and impede a person’s health.

Quite frankly, the consequences of poor pharma packaging are life threatening. The medicine is one thing but getting it to the user is another. To begin with, the material of the primary packaging can change the chemical makeup of the drug/vaccine simply through touch. This is why there was a potential risk of a supply shortage for the distribution of the COVID-19 vaccine. Without knowing the chemical makeup of the vaccine, manufacturers were unable to purchase materials without running the risk of them being a hazard.

Once the materials are selected, they must be perfect. Often, primary packaging must be 100% coated in a distinct substance to protect the contents from any interaction with the plastic, glass or rubber. If there is a single scratch, dent or bubble in this coating, it compromises the medication. In addition to the unwanted material canoodling, parts of that coating can mix into the medication as well.

2) Foreign Substances

Another example of unwanted material is what may lay on the receptacle itself. As with any recipe, a variation to the ingredients of pharmaceuticals will alter the end-result. Therefore, it is crucial to inspect all primary packaging for dust, fingerprints, grease or other foreign substances, including molecules invisible to the human eye.

3) Measurements, Size and Shape

In certain cases, the size and shape of the container must meet the exact design specification as the filling and labelling of the receptacles are automated for speed and accuracy. While on an assembly line, any inaccuracies may result in incorrect dosages.

The same logic applies to the stopper of the container, whether it is plunged or capped. The shape and size must fit exactly to prevent leakage and protects the users who manipulate it.

4) Labelling & Proper Identification

All packaging must be labelled correctly prior to distribution. If mis-labelled, the medication becomes both useless and dangerous. This is the vital information that will contain everything the user needs to know and is equally as important as the medication itself. This applies to all 3 types of pharma packaging. These goods cannot be released without confirmation of its contents.

One Solution to Rule them All

The good news is that all these issues can be address by a single technology. Vision inspection has the capacity to verify and detect the smallest inconsistency. There are several benefits to automated vision inspection including high-speeds, the removal of subjectivity, risk reduction and higher return on investment.

The system itself can be designed to fully control and automate the lighting, temperature, and other environmental factors. As a result, inspection location becomes more flexible. Once a system is designed, the metrics can be manipulated based on the product under inspection. With this data, the same equipment can be leveraged for multiple product types with minor tweaks to the hardware.

Using vision software, limits and requirements are set automatically and the system can run independently with zero operator intervention. In addition, inspection results are automatically logged and organized for increased traceability to support compliance requirements and insight into the product. Naturally, this must be done using a standardized delivery process to assure consistent quality. The right system will also provide a full validation & documentation package to simplify the IQ/OQ/PQ process.

For questions on introducing vision inspection into your manufacturing environment, please contact Averna.

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