Thank you for subscribing to the latest news from Jenike and Johanson about our pharmaceutical offerings. This newsletter covers including preparing for continuous manufacturing, characterizing powder properties during product development and recent developments in applying blend and content uniformity acceptance criteria.
We can assist you with all stages of your product and process development from initial formulation development to scaling-up for manufacturing. We offer a full suite of services, including flow properties and segregation testing, process assessments, root cause analysis of blending and content uniformity concerns and process and equipment recommendations. We have also assisted clients to implement various programs, including meeting quality-by-design (QBD) and specific FDA requirements, to improve quality and reduced time-to-market.
Please contact us if we can assist you with your powder handling challenges.
|Are You Ready for Continuous Manufacturing?
|What key powder properties should be measured during development?|
We are often asked what key powder properties should be measured at different stages of product development, particularly during formulation development vs. validation and commercial production. Learn about the benefits, requirements, and applications of material testing during development and production. Read More
|How do I navigate the evolving blend and content uniformity acceptance criteria?|
|In August 2013, the FDA withdrew the FDA draft Guidance “Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment” (Oct. 2003). Since then, it has been challenging to ensure that uniformity sampling plans and acceptance criteria are properly applied. The ISPE’s Blend and Content Uniformity Working Group formed to develop recommendations and acceptance criteria based on the FDA’s concerns. Read More
|What are the best practices for measuring flow properties in a shear cell?|
Although the value of shear tests is well established, there is often a lack of basic guidance for the characterization of common attributes. Jenike & Johanson’s James Prescott and Andrès Orlando have joined industry and academic scientists in detailing best practices for the characterization of the flow performance, as presented in a new Pharmacopeial Forum chapters (USP General Chapter <1063>). Read More
James Bergum, William Brown, Jon Clark, Thomas Parks, Thomas Garcia, James Prescott, Charles Hoiberg, Sami Patel, and Ravindra Tejwani, “Content Uniformity Discussions: Current Usp <905> Developments Regarding <905> and a Comparison of Two Relevant Statistical Approaches to Assess Content Uniformity”
Zhang, G., Goldfarb, D., Hoag, S., Hancock, B., Prescott, J.K., Orlando, A.D., Holloway, G., “Stimuli To The Revision Process – Proposed New USP General Information Chapter: Shear Cell Methodology for Powder Flow Testing <1063>”.
Bergum, James S., Prescott, James K., Tejwani, Ravindra W., Garcia, Thomas P., Clark, Jon, Brown, William, “Current Events in Blend and Content Uniformity”, Pharmaceutical Engineering, Vol. 34, No. 2, March/April 2014.
Bharadwaj, Rahul, “Emerging Computation Tools for Predicting Mixing of Bulk Solids”, Powder & Bulk Solids, Volume 32, No. 3, March 2014, Industry Insight Column, p.6.
Mehos, Gregory J., “Feed Considerations for Continuous Dryers”, Pharmaceutical Processing, July/August 2014, pp. 24-25.
Bergum, J., Parks, T., Prescott, James, Tejwani, R., Clark, J., Brown, W., Muzzio, F., Patel, S., Hoiberg, C., “Assessment of Blend and Content Uniformity. Technical Discussion of Sampling Plans and Application of ASTM E2709/E2810”, Journal of Pharmaceutical Innovation, From R&D to Market, Volume 9, No.4, December 2014.
October 25 – 29
1. “Addressing Segregation Concerns for a Tablet: Characterization Tests and Root Cause Analysis (Part 1)”
2. “Addressing Segregation Concerns for a Chewable Tablet: Corrective Process and Equipment Modifications to Successfully Produce Registration Batches (Part 2)”
3. “Characterization Tests and Modeling to Address Tablet Compression Rate Concerns”
November 8 – 13
1. Plenary presentation: “Powder Characterization and Trouble-Shooting Methods for Successful Process-Scale up”
2. Co-presentation: “Redesigning an Encapsulator Feed Chute Based on Blend Characterization Data to Minimize Segregation Potential”