Blogs

The concept of Extractables and Leachables (E&L) is well known today, especially since the publication of United States Pharmacopeia (USP) monographs <1663>¹ and <1664>². USP <1663> defined extractables as “organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system and into an extraction solvent under laboratory conditions.” Leachables are defined in USP <1664> as “foreign organic and inorganic chemical entities that are present in a packaged drug product because they have migrated into the packaged drug product from a packaging/delivery system, packaging component or packaging material of construction under normal conditions of storage and use or during drug product stability studies.”

Jia Min Boo and Betty Kim

May 11, 2023

Today I am a Senior Vice President at Novo Nordisk one of West’s biggest customers.

A few years ago, I used to work quite closely with the West team. I clearly remember my first negotiations with West. Our interactions gave me the feeling that your team members had a deep understanding of our patients, the urgency of the particular matter we were negotiating about. I was under no mistake that their attitude and behavior towards my organization demonstrated a thorough wish to continue working together for many years to come.

Lene Hylling Axelsson

May 02, 2023

Nuclear medicine has been extensively used not only to diagnose but also to treat diseases. Radio-labeled proteins and peptides are widely used for this purpose, and glass vials have been traditionally used to store radio-labeled pharmaceutical parenteral dosage forms. One important factor for successful use of the container closure systems (CCS) is how precisely and efficiently the radiopharmaceutical solution is withdrawn from the sealed container. However, due to the generally hydrophobic nature of these compounds, chemical reactions, including product synthesis and purification processes, are often complicated and costly. Overcoming the potential for adsorption of these compounds to the surface of the CCS is key to maximizing the effectiveness of radiopharmaceuticals.

Randy Adachi, Dir, Technical Ops, Daikyo

April 25, 2023

With the growing importance of gene and cell therapies, storage of vial containment systems at ultra-low temperature (-80°C) and cryogenic temperature (vapor of liquid nitrogen, i.e., -130^oC to -180°C) is more common. The primary consideration for storage at such temperatures is that the vial system can maintain container closure integrity (CCI) necessary for the drug product. There are two other considerations for the vial system, considerations more critical at such temperatures than at room temperature – proper filling and proper assembly. These have been discussed in two recent publications by West scientists:

- Volumetric Capacity of Daikyo Crystal Zenith® Vials Stored in Freezing Conditons (Technical Report CZ TR 2022-039)
- Potential Over-Pressurization Issues with Ultra-Low Temperature or Cryogenic Storage of Improperly Sealed Vial/Stopper Primary Package Systems (Technical Service Bulletin TSB 2020-072)

Page McAndrew

April 20, 2023