NEWS & EVENTS

Editorial: Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas

Michael Reel, director of technical services at Alcami, and Quinn McGinnis, process engineer at Alcami, recently contributed to an article in Manufacturing Technology Insights titled Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas. In the article, Reel and McGinnis discuss solutions to pharmaceutical packaging challenges through straightforward case studies.

Even well-designed product formulations can fail if it is contained in inappropriate packaging. How does one decide which packaging to use for a product?

Foremost, packaging has to protect the product from degradation and damage. Material compatibility, water activity, and dynamic vapor sorption testing, and forced degradation studies during development are key in identifiying the risks. different barriers can protect from moisture, light, or gases, such as oxygen or carbon dioxide. Blistered prodcuts may use cold-formed aluminum to block light completely. Vials, at times, use light protective sleeves or amber-colored glass for the same purpose. Bottled products may require the use of a coil to keep tablets from breaking during shipment. These are just a few examples of the ways packaging is used to protect the product from its environment or handling. Early evaluation of the formulated product is pivotal to selecting the right mitigation strategy.

Topics: Editorials Packaging Blogs

The Importance of Secondary Packaging

There are three main types of packaging – primary, secondary, and tertiary – and it is important to understand that all levels of packaging serve specific purposes with specific requirements, in order to get products to people safely, efficiently, and consistently.Primary packaging is what directly encases and contains the drug product. Secondary packaging is the exterior packaging of the primary packaging that groups packages and further protects or labels the drug product. Tertiary packaging is used for bulk handling, storage, and distribution. An example of these packaging levels in the pharmaceutical industry are a vial or blister (primary packaging) placed into a carton (secondary packaging), then packed into a shipping case (tertiary packaging). This article will focus on secondary packaging and the importance of selecting a supplier who is well equipped to handle a product’s unique and customized packaging needs.  

Topics: Serialization Oral Solid Dose Packaging Blogs

Staying Ahead of OSD Challenges

Throughout the development lifecycle of oral solid dosage (OSD) drug products, possible challenges must be immediately addressed to keep timelines on track. In early-stage OSD formulation development, complex solubility issues, difficult-to-formulate products, poorly controlled pharmacokinetics, polymorphism and stability, and limited amounts of the active pharmaceutical ingredient (API) all can lead to delays in development. During late-stage development, product manufacturability challenges can occur with processing and packaging as higher scale manufacturing can significantly impact the physicochemical characteristics of a product.

Topics: Serialization Oral Solid Dose Packaging Blogs

Understanding Pharmaceutical Packaging

For oral solid dose (OSD) pharmaceuticals, decisions regarding the type of packaging used are critical to the success of a product. The best formulated product in the world can fail if it is contained in an inappropriate package. So how does one decide which packaging to use for a product?

First and foremost, the package has to protect the product from damage or degradation. Different barriers can protect from moisture, light, or gases, such as oxygen or carbon dioxide. Blistered products may use cold-formed aluminum to block light completely. Vials, at times, use light protective sleeves for the same purpose. Bottled products may require the use of a coil to keep tablets from breaking during shipment. Alcami works with clients to customize the best package configuration for product protection.

Topics: Serialization Oral Solid Dose Packaging Blogs