Pharmaceutical Package Testing
Pharmaceutical Package Testing
As regulators increasingly look for proof of pharmaceutical product stability throughout the transportation environment, it is critical for manufacturers to ensure that pharmaceuticals are maintained at stable temperatures.
DDL performs thermal performance and distribution simulation testing for pharmaceutical packages as described in PDA Technical Report No: 39 “Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment”. Testing can be conducted at either of DDL’s facilities in Minnesota and California.
Thermal Performance Testing
Over a 72 – 120 hour timeframe, DDL can execute temperature profiles to ensure that a pharmaceutical shipper provides the necessary thermal properties that maintain targeted internal temperatures, protecting the product inside.
Distribution Simulation Testing
ASTM and ISTA provide a majority of the industry guidance where ASTM D4169, ISTA 2 Series and ISTA 3 Series are the primary standards that are used. As professional members of ASTM and ISTA, DDL’s engineers are well versed in these sometimes difficult to understand test standards. DDL consults with customers during the quotation process so that test sequencing and methods are understood and the proper testing is selected as dictated by the package design and intended distribution environment.
- ASTM D4169 “Standard Practice for Performance Testing of Shipping Containers and Systems”
This test method is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements which would be encountered in various distribution environments. A simple example would be shock testing followed by drop testing, then vibration and finally compression. The test plan provides a uniform basis of evaluating, in a controlled and repeatable laboratory environment, the ability of the shipping units and contents to withstand the distribution environment. The test plan uses established testing services methods at levels representative of those encountered in actual distribution. The Distribution Cycle (DC) most commonly used for medical device packages is DC-13 which is designed for the small parcel and overnight shipping mode. Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined.
- ISTA Pre-Shipment Test Procedure for Packages - Through the utilization of tests simulating the shocks and stresses normally encountered during handling and transportation, these tests provide a means for a manufacturer to assign the probability of safe arrival for their packaged products.
Choosing a Pharmaceutical Package Testing Lab
When searching for a pharmaceutical package testing lab, you want to be sure that the company’s testing is unbiased. The best way to assure this is to find a package testing vendor that is independent of any package manufacturers. Unlike other package testing labs that sell both testing and packaging, DDL will never recommend, suggest or urge you to buy a specific brand of packaging.