A simulating leaching (migration) study was performed on a model container-closure system
relevant to parenteral and ophthalmic drug products. This container-closure system …

The interaction between a medical device and a pharmaceutical solution it contacts may
dictate solution safety and/or efficacy. Of specific concern is the ability of device components …

Material/water equilibrium interaction constants (Eb) were determined for 12 organic model
solutes and a plastic material used in pharmaceutical product containers (non-PVC …

This study examines the impact, from a leachables perspective, of charging a solution
contact component of a polymeric solution container. By charging such a container …

Establishing a link between extractables and leachables may be necessary to understand,
interpret, assess, quantify, or control the interaction between a drug product and its …

When drug products contact plastic manufacturing components, packaging systems, and/or
delivery devices, leachables from the plastics can accumulate in the drug product …

Plastic materials are widely used in medical items, such as solution containers, transfusion
sets, transfer tubing, and devices. An emerging trend in the biotechnology industry is the …

Pharmaceutical drug products are packaged in containers so that they can be manufactured,
distributed, and stored. During these events in a drug product's life cycle, the drug product …

Leaching of plastic materials, packaging, or containment systems by finished drug products
and/or their related solutions can happen when contact occurs between such materials …

Lyophilization is commonly used to extend the shelf life of pharmaceutical products that are
otherwise unstable when stored as a liquid formulation. However, the ability of a lyophilized …