White Papers for Pharmaceutical and Biopharmaceutical Manufacturing

  • What is a Stay Interview? (and How to Conduct One)

    Learn what a stay interview is, how they can drive better staff retention rates, and our suggestions for stay interview questions.
  • Aseptic Isolator

    Aseptic isolators are custom designed and crafted to maintain an ISO 5/Grade A sterile productions space. Designed for compliance with regulatory requirements.
  • L.B. Bohle Tablet Coating Technology

    Pharmaceutical film coating represents nowadays an important process step in the pharmaceutical industry. L.B. Bohle is a leader in the development and production of tablet coaters for the pharmaceutical industry. The BFC tablet coater is the high-end version of the tablet coaters and is...
  • Examination of a time release OTC drug by laser diffraction particle size measurement and image analysis

    Modified release dosage form refers to a measured delay on release of drug after it is consumed orally. It prolongs the effect of the drug so that multiple doses are not necessary. There are several terms available to describe “Timed Release Drugs” such as sustained release, prolonged release...
  • Peptide Synthesis Services

    Omizzur focus on custom peptide synthesis services
  • Aseptic Filling Expertise

    Technological developments in the pharmaceutical industry have advanced rapidly over the last decades. One field of particular interest has been aseptic and sterile primary packaging. Primary packaging of pharmaceutical products often involves filling containers (including vials, syringes...
  • 2022 Healthcare & Pharmaceutical Awards Winner!

    Nucl3o announced today that it was named as the “Best Hemp Based Extract Company - Southwest USA”. Awarded by Global Health & Pharma, this honor recognises excellence for services within the healthcare and pharmaceutical industries.
  • Medical/pharma-grade aluminium hydroxide

    The product specification are given in the attached document The product is produced in China in compliance with USP41. GMP is available on request. Product application: commonly used as the main component of compound preparations for gastrointestinal anti-acid drugs that used to treat...
  • Uploaded From lab-bench to large-scale production

    In formulation development, the scale-up from a lab-bench production of small batches to a large-scale production due to a demand for bigger batches, e.g. for clinical trials or economic reasons, can often be challenging. Thus, the possibility to scale-up the manufacturing process is imperative...
  • Counters for bottle filling: What are the problems and can we do something about that?

    When a label on a bottle says “100 tablets”, we assume there are 100 tablets inside, don’t we? Not 99 or 101, but exactly 100. To be more precise, it is expected that the bottle contains exactly 100 undamaged tablets of the same kind. Obviously, bottle filling technology must meet two bigger...
  • The Importance of Customer Service in Pharmaceutical Contract Manufacturing

    With tightening regulations and rising costs, the pharmaceutical industry is being presented with a consistent challenge in the marketplace: Do more with less. As a result, pharma companies are reducing their internal capacities in manufacturing and R&D and are, instead, increasing their...
  • Level and pressure measurement technology for the pharmaceutical industry

    In the biotechnology and pharmaceutical industries, hygiene, consistent performance and flexibility are decisive factors for efficient, as well as safe production with a high degree of automation. VEGA offers worldclass measurement technology for level and pressure. We are specialists in this area.
  • Overcome the Challenges of Small Batch Production

    AST's Matthew Gorton offers insights on solutions to common problems in small batch production
  • Water hammer can and must be eliminated

    Water hammer can be so damaging to machinery and dangerous to human health that every effort should be taken to prevent the hazard. Also known as hydraulic shock, water hammer sounds like a mechanical noise and is sometimes perceived to be a valve slamming closed. In reality, it is a phenomenon...
  • 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...
  • Contained Tablet Coating Success Story

    A customer contacted Freund-Vector asking for a requirement to coat tablets on a LDCS-Pro Hi Coater (150L batches) and needed contained loading, sampling and unloading of their tablets.
  • 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...
  • Application of Low-Frequency (LF) Raman Spectroscopy to an Isoenergetic Polymorph Study

    The importance of polymorphism in the pharmaceutical industry is well established. Much literature exists describing the effect of polymorphs on efficacy, the phenomenon of polymorphism, and the analytical tools available to study polymorphism in active pharmaceutical ingredients and drug...
  • 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...