Downloads

  1. AdVantage Pro Freeze Dryer / Pharmaceutical Lyophilizer
    1/31/2017

    The AdVantage Pro freeze dryer with Intellitronics™ Controller now offers users the benefit of Ethernet communication and email options. Monitor your cycle from anywhere you receive email! Get the convenience of a tray dryer in a benchtop unit.

  2. Freezemobile Shell Bath Freezer
    1/31/2017
    The Freezemobile Shell Bath, a floor model shell bath available in a -75C configuration, helps to decrease manifold freeze drying time. The FSB rotates the flask on its axis thereby coating the interior surface of the flask with frozen product. This increases the surface area of the product-to-energy input, as well as vapor removal; thus helping to reduce the freeze drying process to the shortest time possible when utilizing flasks and a manifold system.
  3. Clinical and Production Pharmaceutical Freeze Dryers
    1/31/2017

    The Benchmark Freeze Dryers are custom-built production pharmaceutical lyophilizers made to meet pilot, clinical supply and production demands. Meeting your current application demands with an eye toward future demand is what we do best.

  4. The Fundamentals Of Freeze Drying Workshops
    1/31/2017

    This program is a survey course covering fundamental lyophilizer operations using terminology and concepts explained in everyday language.

  5. Lyophilization Cycle Development & Optimization: Hands On Laboratory Course
    1/31/2017

    Ideal for Research Scientists Interested in freeze-drying and those that depend on them.

  6. Implementing Next-Generation Laboratory Informatics
    1/19/2017

    Electronic Lab Notebooks are a key component of an electronic lab environment that helps scientists execute faster, more informed, high-quality science. It’s a vision scientists have talked about for decades.

  7. How AstraZeneca Improved Validated Workflows In GMP API Manufacturing
    1/18/2017

    The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API (active pharmaceutical ingredient) manufacture. Paper and its associated workflows were standard only because they were familiar and had been defined over time to meet the needs of scientists, process engineers and quality control and assurance staffs.

  8. Streamlining Change Control In Today’s Complex Life Sciences Organizations
    1/11/2017

    Change control is collaborative, iterative and labor-intensive. For any specific change event, multiple users are required to follow a prescribed set of tasks and processes, which need to be carried out in a defined sequence and are subject to multiple stages of review and approval. It’s very easy to lose track of where you are in the process, what actions need to be completed next, who owns them, and when they are due. Yet the consequences of such lapses can be very costly. This paper examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management, spanning all areas of the organization and extending throughout the product lifecycle.

  9. How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management
    1/11/2017

    In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.

  10. For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research
    1/11/2017

    “Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.