Package Performance Tests

Package Performance Tests

Package performance tests work with the help of specially designed climate cabin and sensitive temperature, humidity chambers and equipment for data collection. It is fully programmed for environmental cycle testing, including in high quality and reliable rooms.

 If we look at the actual objectives of package performance tests;

  •  Drug Stability protocols
  •  Forced Decay Studies
  •  Product Resistance to Environmental Conditions
  •  Thermal Performance of Packaging
  •  Product Quality and Reliability
  •  Product life

In thermal cycling tests, it is very important to develop product and package in order not to damage the efficacy of pharmaceutical products in climatic conditions. The products in the packages protect against hot and humid trips and the packaging itself does not deteriorate as a result of excessive thermal changes according to climatic conditions.

 For example, cold chain packs, which are specifically designed for chambers, medicines, product transport, and to verify those designed, are preferred.

When it comes to what environmental simulation tests mean, it is about designing products for real world uses in simulated test environments. These products are used as early as you can during their lifetime to access test data and performance data. In simulated environmental tests, it is generally expected to create artificial areas for test items for the purpose of determining the expected flexibility to expected environments.

 If we look at the shelf-life intervals determined in medical devices, the aging protocol is accelerated in air-conditioning rooms. If we look at the studies;

 Climate Environment Rooms for Large Projects

 30 ° C to + 60 ° C + 23 ° C ± 1 ° C / P RH ±% 2

 ICH Accelerated (Regions I-IV)

 + 40 ° C ± 2 ° C / u RH ±% 5

 Long Term (Frozen)

 -20 ° C ± 5 ° C ICH

 Cryogenic Storage

 -70 ° C to -90 ° C

 Access and Bench Top Rooms for development work

 -70 ° C to + 190 ° C

 ICH Refrigerated Long Term Storage

 + 5 ° C ± 3 ° C

 ICH Long Term / Accelerated (Refrigerated)

 + 25 ° C ± 2 ° C / `RH ±% 5

 ICH Intermediate (Regions I, II, III and IVa)

 + 30 ° C ± 2 ° C / e RH ±% 5

 ICH Long Term (Region IVb)

 + 30 ° C ± 2 ° C / u RH ±% 5

 In the contents of packaging and testing of packages;

 Environmental air conditioning

 Packaging Materials Testing

 Package Integrity Test

 Environmental testing

 Forced Distortion Study

 Package Strength Test

 Package Labeling

 ASTM and ISTA Distribution Test

 Pharmaceutical Package Testing

 Consumer Product Testing

 We can say that tests such as Shelf Life and Accelerated Aging Test have taken place.

 What are the Benefits of Environmental Testing?

 If we look at the benefits of environmental testing, if it is not necessary according to the contract and the law, it can be achieved by increasing the reliability of the product and reducing the related risk situations in product development. Both countries are legally and internationally regulated. Apart from this, the necessary authorization and authorization certificates are obtained more easily by looking at the types of activities. We can say that the same amount of savings will be realized because of the more use of natural resources during production.

For more information about Package Performance Tests please contact us.