Introduction to Packaging Validation

#MEDISTRI

#MEDISTRI

Medistri continues to be at the forefront of regulatory requirements and quality proficiency.

Packaging Validation stems from the need to ensure the quality of products across the many steps in your distribution cycle: from shipping to storage. It is indeed an increasingly common requirement for many product categories, including a strong emphasis on the packaging quality requirements for medical and pharmaceutical industries. Medistri can validate your packaging according to ISTA 2A, ISTA 3A, ASTM D7386, ASTM D4169.

Packaging Validation is a crucial process that ensures the safety and efficacy of a product's packaging. It involves a series of tests & simulations to verify that the packaging materials and design meet the necessary standards and regulations. The primary purpose of packaging validation is to prevent product contamination, reduce risk, and ensure that the product remains safe and effective throughout its shelf life.

Packaging validation is essential for companies that produce medical devices, pharmaceuticals, and other products that require sterile packaging. Packaging is the first line of defense against product contamination, and any failures in packaging can lead to serious consequences.

If a medical device isn’t :

• Correctly packaged,

• Or in a well designed package,

• Or in a package that is not suited for the product,

• Or in a package that is not suited for the transit,

👉 ... it could become contaminated with bacteria or other pathogens, which could lead to infections or other adverse events. Similarly, if a pharmaceutical product is not packaged correctly, it could degrade over time, leading to a loss of potency or even toxicity.

Packaging validation is also important for regulatory compliance. Regulatory agencies such as the FDA and EMA require companies to demonstrate that their packaging materials and design meet certain standards for safety and efficacy.

Packaging Validation for medical devices & pharmaceutical goods is segmented into three categories:

• Environmental Conditioning.

• Transport Simulation (or also known as Transit Testing).

• Integrity Testing (or also known as Sterile Barrier Integrity Testing).

Packaging Validation examines the interactions within the handling and use system, which encompasses the manufacturing system (including sterilization), human interaction with the package, distribution, storage system and environment.

👉 To help ensure that the anticipated results are achieved, the Packaging Validation is performed by someone with the necessary education, background, training, experience, and qualifications for each particular function.

✔ The validation process is documented and approved.

There are several types of packaging validation tests that Medistri can use to ensure that your packaging materials and design meet the necessary standards and regulations. These include:

• Atmospheric Preconditioning.

• Atmospheric Conditioning.

• Mechanical Handling Test.

• Compression Test.

• Concentrated Impact Test.

• Free Fall Drop Test.

• Fork Handling Test.

• Low-Pressure Test.

• Loose Load Vibration Test.

• Fixed or Random Vibration Test.

• Incline Impact Test.

• Rotational Drop test.

• Accelerated Ageing Tests according to ASTMF1908.

• Real-Time Ageing Tests.

• Visual Inspection Tests according to ASTMF1886.

• Dye Migration Tests according to ASTM F1929 & F3039.

• Bubble Emission Tests according to ASTM F2096.

• Seal Tensile Strength Test according to ASTM F88.

• Peel Strength Test according to EN 868-5.

• Burst Test according to ISO2758.

Regulatory agencies such as the FDA and EMA require companies to demonstrate that their packaging materials and design meet certain standards for safety and efficacy. Some of the regulatory requirements for packaging validation include:

👉 ISTA 2A.

👉 ISTA 3A.

👉 ASTM D7386.

👉 ASTM D4169.

👉 ISO 11607–1.

Regulatory compliance is critical for ensuring that a product's packaging materials and design meet the necessary standards and regulations.

Should you fully validate your packaging system or should you simply test one particular characteristic of your sterile barrier system, Medistri laboratory is accredited and highly experienced for the most common tests methods provided by the regulatory agencies.

🎯 To learn more about Medistri’s Packaging Validation services, visit on our website at www.medistri.swiss or directly contact our team at contact@medistri.swiss.

- The Medistri Team

#Medistri

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