Pharmaceutical & Biologics Packaging Testing

When a compound is complete and ready for packaging and shipping, the processes of compliance and due diligence are still extremely relevant. Testing using a range of methods is necessary to ensure that products are not contaminated or compromised.

A few primary forms of testing are necessary when packaging, processing, and transporting pharmaceuticals or biologics. These include E&L testing, container closure integrity, and shipping distribution testing.

What Is E&L Testing?

Extractables and leachables (E&L) are types of materials that can migrate from a packaging system component (i.e., container or closure system) and can contaminate a final product.

Comprehensive testing is required to analyze the variety of possible materials to ensure compound purity. Extraction techniques follow standards set forth by USP and ISO guidelines. These can include techniques such as Reflux, Sonication, Microwave, and Incubation, and they are used to determine if a foreign extractable is found within an object.

After performing these extraction techniques, semi-quantitative screening methodologies are used to analyze extraction solutions through instrumentation, chemical screens, and more.

What Is Container Closure Integrity Testing?

One of the most crucial steps in understanding the safety and suitability of primary packaging is understanding if a container closure system can maintain a stable, sterile barrier. There are two different types of testing mechanisms that regulatory agencies find as useful and permitted - probabilistic and deterministic tests.

Utilizing Probabilistic Tests

Probabilistic tests are tests that help determine if there is a probability of a break in the container closure integrity.

  • Dye Immersion Testing - Packages are fully submerged in a dye bath, and vacuum pressure is applied. The packages are then visually compared to a sensitivity solution to evaluate the samples for dye presence inside the containers.
  • Microbial Immersion Testing- This type of testing determines if microorganisms can permeate into a closed container.

In 2016, USP issued guidance that deterministic methods are preferred over probabilistic. This guidance is primarily because they can achieve reproducible and predictable results.

Utilizing Deterministic Tests

A wide variety of deterministic tests have been developed and are frequently used in the testing of container products:

  • Vacuum Decay: Measures leaks by vacuum decay. This technique is used mainly on vials and syringes.
  • Pressure Decay: Measures leaks by pressure decay. Best used for flexible products like bags or pouches.
  • High Voltage Leak Detection: Detects package defects using an electrical current. Best used for glass products filled with liquids.
  • Oxygen Headspace: Uses Frequency Modulation Spectroscopy (FMS) to detect oxygen in transparent rigid containers and measure leaks. Ideal for a wide range of uses.
  • Helium Leak Detection: Quantitates the helium flow rate from leaks in packaging after being charged with helium as a tracer gas. This is the most sensitive testing option.

What Are Shipping Distribution Studies?

From the primary seal testing through pallet-level transit testing, there are a variety of ways that your product still requires evaluation before transportation and delivery to the consumer. Shipping distribution testing and compliance is required by many regulatory agencies and is just as critical as other testing forms.

Package testing is required to perform functional testing, comprehensive material testing, and help determine the shelf life of packaging. Every aspect of packaging needs to be tested - even the durability of labels!  

Two primary types of testing are essential in this process - stability testing and distribution testing.

What is Stability Testing?

Stability testing is used to simulate specific conditions that a package, packaging component, or its container, may go through during its life cycle. Some of these include refrigerated storage, extreme cold, extreme heat, humidity, dryness in the air, and other standard atmospheric conditions.

What is Distribution Testing?

Distribution testing is necessary to ensure that products meet the international submission guidelines for transport. Distribution testing includes vibration testing and loose load handling, manual handling, drop impact, crush testing, and low-pressure testing. Some tests even include altitude testing for high-pressure situations.

The Medizap Difference

Testing is critical to ensure that your packages and compounded products maintain the highest compliance level and are entirely pure. Utilizing a wide variety of proven and regulated testing methods is the best way to do this, and you can trust that Medizap has strong processes and partnerships in place to meet all of your packaging testing needs. Contact us to learn more!


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