Previous Blogs

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By Liang Fang Ph.D.

November 11, 2021

The drug and packaging industries have always been extremely conscientious to ensure that anything added to a delivery device to improve performance (e.g., silicone oil used to coat the inner surface of a syringe barrel), does not affect a drug’s efficacy or safety. But what about the converse? How do we make sure that the drug, or more specifically its added excipients, does not affect the delivery system’s performance? The term excipient refers to any member of a broad group of surfactants, preservatives, tonicity agents, and buffers which formulation scientists take great care to balance in order to provide the drug, such as a therapeutic protein, in its most effective and deliverable state.

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By Candice Sun

May 20, 2021

Synthetic rubber has replaced natural rubber in many fields over the past decades. Very notable are the synthetic halobutyl rubbers used as a base for pharmaceutical elastomer components. They are an excellent choice due to their attributes of low permeability to air and moisture, excellent aging resistance, and low level of extractables. Halobutyl rubbers are available in two types, chlorobutyl and bromobutyl; both can be manufactured by co-polymerization with halogenated monomer.

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By Birgit Mueller-Chorus, Ph.D.

May 06, 2021

Moisture-sensitive drug products are commonly lyophilized to enhance their shelf life and to prepare them for storage and transport. Maintaining a constant moisture level in a lyophilized drug product “cake” ensures product quality. Not only is proper selection of a container closure system (vial, stopper, seal) necessary, but sealing conditions are as well. This is achieved through demonstration of container closure integrity (CCI).

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By Birgit Mueller-Chorus Ph.D.

April 27, 2021

For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.

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By Eric Tan

December 15, 2020

To ensure drug product efficacy, components of primary packaging and delivery systems must be evaluated for safety and performance. An essential aspect of this is an extractables and leachables (E&L) study. The purpose of an E&L study is to identify compounds (organic and inorganic) that may migrate from components into drug product formulations, in particular those that may put patient safety at risk.