Topic

Articles

Consider the time and expertise needed to maintain regulatory compliance and perform stability testing.

Considerations for Outsourcing Stability Storage

Today's pharmaceutical companies are striving to reduce costs and maximize efficiencies, and must make decisions on the best way to deploy their limited resources.

Outsourcing Pharmaceutical Infrastructure Operations

Our company needs more stability storage. What issues should we consider when deciding whether to build our own biorepository facility or outsource our storage?

Considerations for Outsourcing of Stability Storage

Identifying and classifying rouge can help to determine CAPA.

Classifying Rouge Helps Define Remediation Procedures

Flexible, scalable control systems use program batch sequencing.

Implementing a Cost-Effective Cure for Batch and Sequence Management

We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?

Product Neutralization for Rapid Microbiological Test Methods

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

Lyophilization: How to Meet Scale-Up Challenges Using QbD

My application uses a peristaltic pump with silicone tubing running through it and a different, heat-sealable tubing material before and after the pump section. Recently, an operator installed the wrong section of tubing in a pump, resulting in lost API, equipment replacement, and hours of extra work. How can we avoid this kind of mix-up in the future?

Working with Tubing for Peristaltic Pumps

New coating technologies achieve high uniformity and reduce waste through mixing system advances and pan and airflow configuration.

Advanced Tablet-Coating Technologies Aid Manufacturing Efficiency

We are using a vacuum oven to dry our wet-cake intermediate. At 120 °C, it takes 26 hours on average to dry the material from 80% to 10% moisture. Can we shorten our drying time, possibly by agitating the product to improve heat transfer?

Troubleshooting