FEATURED ARTICLES

• Developing A Disposable Grade-A Aseptic Fill/Finish Isolation System

  Flexible film isolation has been used in aseptic processing since the 1970s, but these systems tended to be a composite of stainless-steel chambers and airflow modules with a flexible film user interface. 

• 8 Key Factors When Selecting A Powered Air-Purifying Respirator System

  This white paper explores eight considerations in detail and could be helpful to EHS managers and supervisors looking to select a Powered Air-Purifying Respirator system for their particular application.

• Containment Solutions For Safe Handling Of HPAPI Chemical Synthesis

  With high potency active pharmaceutical ingredients (HPAPIs) comes a heightened awareness of this requirement and the added burden of a higher level of regulatory oversight.

• How To Boost Profits With Single-Use Powder Transfer In Biopharma

  Does your powder system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?

• Methods Of Containment For Solid Dose Blending And Manufacturing

  Two methods of containing blenders have been demonstrated. Included here are the use of flexible enclosures and separate, disposable powder transfer systems.

• Facing The Challenges: Single-Use Approaches To Powder Transfer

  Media and buffer preparation is a key part of the biopharma manufacturing process. Improving the powder transfer process makes this step cleaner, safer, more efficient,and reduces costs. 

• Fluid Transfer Assemblies Quality Guidance

  Learn about the structures and processes within ILC Dover’s quality system, which their Fluid Transfer Assemblies is manufactured under, along with the packaging and delivery of these assemblies.

• Achieve High Containment, Reduce Cross Contamination Risk

  Technology has evolved to make high-containment systems financially reasonable. Explore how single-use containment technology impacts capital spending and operating expenses.

• Modern Containment Solutions In OSD Processes

  In the containment world for OSD processing we see smaller batch sizes and more changeover. Here we consider the pros and cons between hard-wall systems and flexible-wall containment systems.

• Highly Potent Active Pharmaceutical Ingredients Containment

  Review a full lifecycle safety structure that ensures the highest standards of operator protection from single-use flexible film containment systems.

• Innovations In ADC, Highly Potent Substance Containment

  This webinar covers a well-designed, single-use flexible enclosure system that delivers equivalent if not better containment performance than a hard-shell isolator, at a fraction of the cost.

• Intro To High Containment For Lyophilization Processes

  This white paper explores the advantages and disadvantages of lyophilization as well as lyophilizer solution examples and containment designs.

• Flexible Isolator Technology – Containment That Works

  This webinar focuses on applications where flexible isolators have been used, including containment assessments to confirm performance and ergonomic benefits. 

• High Containment Single-Use FIBC For Pharmaceutical Powder Handling

  This webinar focuses on moving the HPAPI powders thru the entire process starting with chemical synthesis of the molecule to finishing in multiple solid dosage forms.

• The Right Transfer Solution For Media And Buffer Powders

  Learn about best in class solutions to streamline the transfer process, resulting in more accurate and faster production and improved batch cycle times.

• The Rise In Single Use Containment For CMOs

  The on-demand webinar CMO/CDMO Facilities Gain Value with Single-Use Containment presents a case study for an OSD process, shared facilities and HBEL/ADE requirements.

• A Proven, Cost-Effective, Single-Use Powder Transfer Solution

  Powder-handling processes haven’t kept pace with advances in single-use transfer technologies. This application note posits a better way to bring powders to the hydration process for upstream manufacturing.

• Single-Use Systems For Charging And Offloading Pharma Powder Transfer

  Don’t risk operator exposure and potential contamination with untested or unproven single-use valve technologies. 

• Rapid Large-Scale Mixing Of Clumped Powder In Pharma Manufacturing

  For operations where low shear and high product integrity are required, traditional technologies pose a risk to the quality of the final product.

• Boost Profits With Single-Use Powder Transfer In Biopharma Manufacturing

  While media and buffer materials have been notorious contributors to airborne particulates and contamination in the past, they don’t have to be. 

• Get Your Biologic To Market Faster, With Less Risk

  Upgrading to modern single-use powder handling gets your product to market without time wasted on complicated weigh and dispense steps, cleaning validations, or worries about powder in the air.

• Cost Advantages Of Single-Use Isolator Technologies In High-Potency Drugs

  The current trend of increased potency of drug substances is driving the need for better cleaning methods to reduce cross contamination. 

• Utilizing Single-Use Powder Handling To Reduce Contamination

  Read how upgrading to modern single-use powder handling gets a product to market without time wasted on complicated weigh and dispense steps, cleaning validations or powder in the air and in the suite.

• FAQ's: Regulated Films For Containment Solutions

  At ILC Dover, we are always "creating what’s next" by listening carefully to our customers. In response to customer input and emerging regulations, we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.

• A Novel Design To Contained Transfer Of Drummed Materials Using A Disposable Manufacturing Approach

  The Drum Transfer System (DTS) described in this article has been validated in a variety of processes requiring the contained transfer of drummed materials in pharmaceutical applications. Processing operations described here include milling, subdividing, charging, and repackaging. Submitted by ILC Dover

• G2Pac™

  Product Sheet: G2Pac™

• The Answer To Final Pack Off Containment

  The DoverPac® continuous liner system provides the advantage of replacing packs without breaking containment, unlike using inflatable heads or having operators shuffle tube stock.

• Flexible Containment Solutions Guide: Mill Containment System - Jet Mills

  The process for this application consists of the controlled feeding of a mill through a feeder. The powder is introduced into the feeder using a drum transfer system.

• Flexible Containment Solutions Guide: Document Transfer Enclosure

  The Flexible Document Transfer Enclosure is designed to allow paperwork used in pharmaceutical processing to be handled in a contained way so that powders are not transferred onto the documents and to areas or individuals that are not protected.

• Flexible Containment Solutions Guide Mill Containment System — Underdrive Design

  White Paper: Flexible Containment Solutions Guide Mill Containment System — Underdrive Design

• CMOs Of Potent Products Seek Flexible Containment Systems To Increase Safety And Profitability

  The interest in the use of containment for the development and manufacture of active pharmaceutical ingredients (APIs), including sensitizers by contract manufacturers and contract research organizations, is expanding. By Alan E. George, ILC Dover

• Application Note: Retrofitting Process Equipment Achieves Containment For A Range Of Manufacturing Operations

  This article provides a review of various innovative solutions, a provocative thought process for customized installations if needed, and a look at a technology verified to reduce the overall cost of ownership for contained processing. By ALAN E. GEORGE

• Flexible Containment Solutions Guide: Coaxial Neck DoverPac®

  Given the increase in highly potent API manufacturing, the use of the Coaxial neck DoverPac® system, with either rigid isolators or flexible enclosures, is a complementary processing option. By ILC Dover

• Flexible Containment Solutions Guide: Drum Transfer System

  Flexible Containment for offloading drummed materials in a safe and efficient manner is provided by the Drum Transfer System (DTS) platform. The DTS consists of an enclosure attachment frame, a support stand, a drum lifter, an enclosure, an outer drum sleeve, and discharge softgoods that are dependent upon your process equipment.

• Creating A Drum Transfer Solution

  One of the simplest, most convenient and most cost-effective ways to ship, receive, and store bulk powder ingredients, including active pharmaceutical ingredients (APIs), intermediates, excipients, and ingredients for buffers and media, is in drums. The contents of these will need to be transferred before use, and this process can be challenging. Integrated drum transfer solutions make the process simpler, cleaner, and faster, improving safety for both workers and patients, as well as protecting any remaining ingredients for storage.

• Flexible Containment Solutions Guide: Document Transfer Enclosure

  The Flexible Document Transfer Enclosure is designed to allow paperwork used in pharmaceutical processing to be handled in a contained way so that powders are not transferred onto the documents and to areas or individuals that are not protected. Submitted by ILC Dover

• 7 Things You Need To Know About Biopharmaceutical Powder Charging With Flexibles

  Alan George is the Product Manager for ILC Dover’s flexible containment and disposable systems and has been actively supporting the development of flexible containment solutions for a wide range of processing equipment for over 13 years. In this Q&A, Alan responds to 7 questions concerning the use of flexibles to support powder charging in biopharmaceutical operations.