ILC Dover has been developing solutions for the pharmaceutical and biopharmaceutical markets since 1997. We pioneered single use Flexible Containment to address safe powder handling of potent compounds and we’ve recently created a breakthrough solution (the EZ BioPac®) used in the efficient production of media and buffers for biopharmaceutical operations. Through a strategic acquisition we also offer a full line of powder processing equipment. All of our life science products leverage technology solutions from our product base including the space suits for NASA, advanced airships, and innovative respiratory protective equipment.
To create the most effective single use solutions we’ve used our vast material development experience to create the ArmorFlex® line of films. These regulatory compliant films are custom formulated by ILC to deliver superior elongation performance (nearly 500%) which translated into increased ruggedness and high strength. This feature coupled with a unique blend of safe and effective anti-static additives allows all of the DoverPac® products to deliver reliable high-level powder handling performance.
ILC’s manufacturing facilities include an ISO Class 7 Clean Room. This clean room and our customized production equipment allow all of single use products to be produced to the most exacting standards.
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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.
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.
Systems should be analyzed not only for their basic ability to contain the powders of interest, but also for how efficiently they integrate into the production process. For instance, will the 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?
Media and buffer preparation is a key part of the biopharma manufacturing process. Improving the powder transfer process makes this step cleaner, safer, and more efficient, and costs as well.
Two methods of containing blenders have been demonstrated. Included here are the use of flexible enclosures and separate, disposable powder transfer systems.
Scott Patterson, VP of Commercial Sales, along with Business Review presented a webinar entitled: CMO/CDMO Facilities Gain Value with Single-Use Containment. In this webinar Scott discusses flexible containment, containment performance using a case study for an OSD process, shared facilities and HBEL/ADE requirements, and benefits global CDMO’s realize with flexible containment.
Single-use transfer technology has been used in biopharma manufacturing for years. However, upstream powder-handling processes haven’t been improved upon. Now, the industry is seeing a need for better ways to bring powders to the hydration process and begin upstream biologic manufacturing.
Don’t risk operator exposure and potential contamination with untested or unproven single-use valve technologies.
For operations where low shear and high product integrity are required, traditional technologies pose a risk to the quality of the final product.
While media and buffer materials have been notorious contributors to airborne particulates and contamination in the past, they don’t have to be.
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.
The current trend of increased potency of drug substances is driving the need for better cleaning methods to reduce cross 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.
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.
At ILC Dover we are always “creating what’s next” by listening carefully to our customers.
Article: Test Area Validation And Flexible Containment System Performance: Testing To The SMEPAC 2005 Guidelines
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
Compatibility Chart: Protective Suit Materials Against Chemicals
Protection Factor Test Results: Chemturion™ Model 3525
Product Sheet: Chemturion™ Model 3525
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.
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.
White Paper: Flexible Containment Solutions Guide Mill Containment System — Underdrive Design
The pharmaceutical industry is insisting that manufacturers provide test data on containment systems they are considering for installation and use. Testing must be performed by a reputable third-party test company with industrial hygiene (IH) experience, and must be conducted in a consistent and defendable manner using standard methodology. This article describes the design and production of a test facility, along with the third-party validation and testing of that facility using the SMEPAC guidelines. Submitted by ILC Dover
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
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
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 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.
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.
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
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.
CMO and CDMO facilities have experienced fast paced growth and with more potent compounds planned for launch in the future the good times will continue. There are unique problems with growth for these contract facilities and many have to do with the controls required to assure proper containment of compounds in a multi-use facility. Containment is critical to assure personnel are not exposed to the affects of the drugs and to mitigate issues with cross contamination. These additional controls require greater attention to SOP’s particularly for cleaning and validation. These cleaning procedures reduce the uptime of equipment or process suites then limiting the facility to take on more campaigns and grow faster. This is where single use containment can expedite the changeover in campaigns while still providing the needed controls.
MEP Deirdre Clune officially opened the new ILC Dover manufacturing facility in Blarney Business Park, Cork today (Tuesday) alongside ILC Dover CEO and President Fran DiNuzzo.
At ILC Dover we are focused on containing your process to get your product to market faster, safer, and cleanly.
The rare Ebola virus has set out on another deadly rampage. This latest outbreak in the Democratic Republic of Congo is the worst in the country’s history—more than 400 people have died from the epidemic since August. Obviously tragic for its victims, the virus threatens the healthcare providers who care for these victims as well.