White Papers for Pharmaceutical and Biopharmaceutical Manufacturing

• Check Valves Assembled to Order When You Need Them

  When a check valve breaks or malfunctions, it may cause an entire system to break down. A new, high-quality check valve is needed—and it’s needed immediately. While a company may have a backup valve they can use in the meantime, it’s still necessary to get the replacement quickly. Check-All...

• Improve Sterility Assurance And Data Integrity 503B Compounding

  Sheila Dell, Ph.D, discusses automated technology and how it can improve sterility assurance and data integrity in the compounding sector.

• How Does USP 800 Affect Urology Practices?

  Two commonly used drugs in urology, Mitomycin and Gemcitabine, are included on the NIOSH list. As hazardous medications, USP 800 requires significant investment to safely compound and administer doses of these drugs. Edge Pharma developed a solution that solves this issue for hospitals, surgery...

• How to Achieve Data Integrity in the Laboratory

  Lack of data integrity is the main reason for most FDA warning letters. For laboratories that must comply with GLP, GMP and GAMP regulations it is important to have records or documented evidence of all relevant analyses that can be checked by a second person and are also readily available...

• Are Sterile Bioprocess Containers A Source Of Particulate Contamination?

  We suggest that containers which are not produced to a recognized standard of cleanliness are a potential source of contamination.’ This article discusses why this is a problem for biopharmaceutical and vaccine manufacturers, the nature and source of possible contaminants, and a readily...

• Making it clear – the water quality standards of NSF/ANSI 61 and 372

  To make the products safe for water distribution there must be protective barrier material, joining, and sealing materials. These materials will ensure that the water remains free from any contaminates that may be present on or in the metal, paint, gaskets, lubricants, etc. NSF/ANSI has...

• Lot Size One and Up: Dividella’s approach to small-batch production

  Top loading packaging experts Dividella have adopted the ‘Lot Size One and Up’ approach rooted in Pharma 4.0 concepts. This is based on a robotic work-cell system that boosts the flexibility and sustainability of small-lot production to relieve stress points for pharmaceutical manufacturers...

• Data Logger vs DAQ

  Key Differences Between Data Logging and Data Acquisition What is the difference between a Data Logger vs DAQ System? A data logger is a type of data acquisition system, but a data acquisition system is not necessarily a datalogger. There are several key functional differences in how the market...

• The story behind Ocean Optics - How we did it!

  Ocean Optics went from a 4' x 6' humble beginning to a premier developer and supplier of the "World's First Miniature Spectrometer" Innovative engineering and equally innovative marketing are part of the "How we did it" story.

• SCALE-UP AND TECHNICAL TRANSFER FOR LYOPHILIZED PRODUCTS

  Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. The...

• Sherpa Guide EU Annex 13 Labeling

  The purpose of this guide is to walk US-based clinical supply professionals through the labeling requirements laid out in Annex 13 of the EU GMP guidelines. This annex details guidance for Investigational Medicinal Products (IMPs), and this handbook will focus only on those Articles applicable...

• Russell Compact Sieve® provides solution to high-capacity containment sieving

  Engineering house combines high containment isolator with hygienic and efficient pharmaceutical sieving solution to provide customized unit.

• Analysis of Two API Products Using the Opt-Diss 410 UV FIber Optics with Multi-Component Analysis

  This white paper explains the theory behind the MCA algorithm methodology. Then, used in tandem with in-situ fiber optics, the accuracy of the technique is demonstrated by recovering the concentration of two APIs in known mixed solutions. Finally, an example is given of accurately monitoring...

• TECHNOLOGY OVERVIEW AND APPLICATIONS IN THE PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRY

  In this article Dr Richard Johnson, Founding Director of Upperton Ltd, describes some of the basic principles of spray drying and how spray drying is typically being used in the pharmaceutical and biotechnology industry. Particular attention is focussed on four key applications, namely the...

• Beyond the Basics: The Benefits of an ERP Solution for Small and Mid-Sized Nutraceutical Manufacture

  An ERP solution developed for small to mid-sized nutraceutical companies that use batch process manufacturing needs to go beyond the basics of an accounting and Microsoft Excel-based system, or even a one-size-fits-all ERP solution. An industry-specific ERP will provide you with a higher level...

• The FDA expects organizations to have full visibility and control over their processes

  Expectations include: • Understanding products and processes in order to implement Quality by Design (QbD) into product development • Delivery of quality metrics for risk-based inspection schedules as proposed by a new quality metrics program • Shared responsibility for products manufactured...

• Determining Extractables and Leachables in Polymeric Materials

  Jordi Labs determines extractables and leachables in polymeric materials.

• 4 ways for Serialization Success

  As the Drug Quality and Security Act’s (DQSA’s) Novem- ber 2017 deadline approaches for serializing saleable units of prescription pharmaceuticals, many pharmaceu- tical companies, particularly small to mid-size organiza- tions, are just embarking on the serialization journey. There are four...

• Chemical Safety: How to Store Laboratory Chemicals and Minimize Risk

  Proper chemical storage is critical to minimizing risk in a laboratory or industrial setting. The safe storage of hazardous substances is an essential part of any environmental, health, and safety program for your lab. To minimize liability and reduce the risk of an accident occurring it is...

• Why Do I Need a Cleanroom?

  The electronic, high-tech, semiconductor, pharmaceutical, aero space, medical and many other industries depend on cleanroom technology. As products such as cell phone circuit boards become smaller, the chance of contamination in manufacturing becomes higher. For pharmaceutical companies, clean,...

• Things to Consider When Choosing a Data Logger

  There are many factors to consider when selecting the right data logging solution for your specific needs and application. MadgeTech offers top of the line data loggers, accessories, systems and advanced data logging software. Since MadgeTech engineers and manufactures all of the data loggers...

• Taking the Mystery Out of Moisture Analysis

  Learn how to get the most accurate results from your moisture analyzer.

• Recent Technical Advancements in Blow-Fill-Seal Technology

  Blow-fill-seal technology, originally developed in Europe in the 1930s and introduced in the US in the 1960s, has emerged as a preferred method for aseptic packaging of pharmaceutical and healthcare products due to unrivalled flexibility in container design, overall product quality, product...