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.
ILC Dover is 100% focused on containing your process to get your product to market fast, safe, and pure. Our single-use containment solutions leverage our patented and industry-leading ArmorFlex® films to deliver extreme durability for a lower cost.
ILC Dover’s Liquid Single-Use BioProcessing Bags are single-use containers for fluid storage and transfer in cGMP manufacturing.
Our JetBreaker powder delumping system allows for the addition of difficult to mix powders that have large clumps to keep your process moving and allow you to dissolve powder more rapidly.
The efficient mixing of media and buffer powders into liquids is a crucial step in profitable pharmaceutical and biopharmaceutical manufacturing. For operations where low shear and high product integrity are required, no other technology performs as well as the patented venturi system used by the ILC Dover ArmorFlex® Powder Mixer.
Product containment and processing of small-scale lab operations can cause a headache if they are irregular or infrequently performed. A costly acquisition of a large-scale containment unit simply isn’t an option for many laboratory applications.
Our classic flexible film isolator that is popular in lots of laboratory settings.
The soloASEPTIC system has been designed to accommodate a variety of aseptic processes in a single-use disposable isolator. Allowing for flexibility in your facility this system works around your needs.
The all-rounder, star of the show. Ready to plug-and-play isolator for various applications in the pharma manufacturing process. Upgrade your existing plant to handle higher potency compounds and adapt to the changing marketplace.
Antibody Drug Conjugates (ADC’s) have become vital in the fight against many different types of cancer. The high potency nature of the toxin part of the ADC means you need to maintain the upmost operator safety while still running an efficient process. That’s why we developed the soloADC! Designed and manufactured in conjunction with an CDMO already handling the hazardous process, we developed this system which takes into all considerations when it comes to keeping both the people and products safe. With zero cleaning validation required the potential cost and time savings associated with cleaning validation are huge.
The Sentinel XL® HP is a high performance PAPR system (Powered Air Purifying Respirator) specifically designed to provide healthcare professionals with superior respiratory protection against a range of infectious diseases.
The Sentinel Clear PAPR offers state-of-the art respiratory protection for pharmaceutical personnel and other life science professionals.
The JetVent system allows for easy and confident handling of expensive and dangerous powders.The pressure inside the enclosure measured with high precision is used to control fan speed and gas inlet.
In the pharmaceutical industry, granulation is used to create bonds between particles as part of the oral solid dosage manufacturing process. ILC Dover supplies a family of products that support contained granulator operation and features validated containment technology, clear film, and the ability to retrofit to existing equipment design.
Milling is a common operation throughout the pharmaceutical manufacturing process. Sizing of powders is a dusty operation and with more potent powders being processed, the need for containing this operation becomes even more critical from safety and cross contamination avoidance purposes.
Tablet coating is a common operation throughout the pharmaceutical manufacturing industry. ILC Dover supplies a family of products that support contained Tablet Coating operation.
Tablet compression is a common operation throughout the pharmaceutical manufacturing industry. ILC Dover supplies a family of products that support contained Tablet Compression operations.
DoverPac® Containment Systems, an ILC Dover brand, is the global pioneer of disposable process and powder containment systems.
The ILC Dover Continuous Liner is an easy-to-use system that has been proven effective in containing active pharmaceutical ingredients and other hazardous compounds.
ILC has adapted the DoverPac® Flexible Containment Technologies to include enclosures for almost any process. Use of the ArmorFlex® film and integral gloves and sleeves will support operations from filter dryer discharge and heel removal to tray dryer loading and unloading. The benefits of this technology are:
The Ventilated Enclosure System combines the benefits of Flexible Containment with a unique, light weight ventilation unit. This system provides all the advantages of a negative or positive pressure isolator providing reduced costs for cleaning and validation with the disposable enclosure that is utilized.
De-agglomeration of powder blocs according to GMP standard.
The Jet Feeder is a multi purpose system for feeding powders into liquid and for low shear mixing. It is the perfect unit to use on those products that are sensitive to shear. ILC Dover completed a successful test at a pharmaceutical facility for mixing starch into solution for a tableting process. The system is cGMP, easy to clean or CIP, and will work in single pass processes or recirculating processes. JetSolutions is an ILC Dover company and is the manufacturer of the Jet Feeder.
The homogenizer is working as a particles size reducer for particles in suspension in a liquid and to calibrate their size at a defined value.
A manual or automatic sampling valve can be adapted at the hopper or container powder outlet with a standard containment or bottle system.
The pneumatic POSITIVE pressure conveying (or PRESSURE conveying) is dedicated to the transfer of larger quantities of powder or granulates under following conditions:
The negative pressure conveying is dedicated to small quantity of powder or granulates when:
The mixer is loaded with the individual raw materials exactly according to the formulation. The combination of Dosicon® weighing equipment with suction conveying units fulfils this task. Fundamental advanrages of JetSolutions automatic multi-component dosing are high dosing accuracy (for quantities ranging from a few hundred grams to several hundred kilos), the prevention of cross-contamination risks, and freedom from dust.
The PST system can be operated in batch or continuous way. A set of valves allows the discharge or the re-circulation of the mixture. The powder characteristics and the flow capability will define whether a longer sucking time is required.
Dust-free bulk powder transfer from cardboard boxes, sacks or drums by means of a feed hopper with weighing frame. Positive raw material identification and registration by means of barcode scanners.
The DOSIMAT valve allows a precise dosing of any powder or granulate when filling drums, bags, boxes, big-bags, etc.
«IBC» means «Intermediate Bulk Container». An IBC is therefore a mobile, flexible and rapid storage device for any powder or granulates.
The DOSICON discharge station has been developed and patented by JetSolutions SA for discharging the DOSICON containers (IBC).
Thanks to its weighing terminal IT 9000 as well as its dosing device Multi-Dosimat, JetSolutions SA offers reliability and precision for filling powders or granulates into IBCs, boxes, bags, trucks, etc.
Storage of pharmaceutical compounds is a function of the storage process and not a specific containment driven requirement per se. This is the case whether you are processing in a contained fashion or performing non-contained processing into open kegs with simple drum liners.
ILC Dover brings a unique history and skill set to the biopharmaceutical industry, particularly single use biopharmaceutical powder handling and containment equipment.
Guardian drum liners are an efficient and economical solution to the headache and expense of cleaning and/or disposing of used drums.
The clean room produced liners are designed for use in FIBCs, IBCs, corrugated boxes, bins or totes. The form fit design allows for a consistently complete fill and dispense of products because the liner has no pleats, folds or other traps to hinder material flow.
Guardian Form Fit Foil liners for hygroscopic dry bulk materials in FIBCs, IBCs and corrugated boxes improves package performance and protects.
Flexible Intermediate Bulk Containers, FIBCs or bulk bags are large woven polypropylene bags designed for storing and transporting dry flowable bulk products.
Buckhorn reusable intermediate bulk containers from Grayling Industries are designed to provide maximum product protection, hygiene, and efficiency.
The PaperIBC container from Grayling Industries is a dependable, economical and environmentally responsible alternative to drums, bottle-in-cage and other “heavy footprint” types of intermediate bulk containers.
EZ BioPac is meeting the challenges of biopharmaceutical powder manufacture. The EZ BioPac single-use system is the fastest, most efficient solution. Its larger diameter top opening permits easy filling and fine-tuning of final weight.
ILC Dover pioneered flexible containment for the pharmaceutical industry and continues to innovate processes for better performance.
ILC Dover has worked with our customers to develop Flexible Containment Solutions for a wide variety of processes within the pharmaceutical industry.
Another proven method for cGMP processing is also available now using drums, a conical drum funnel and drum lifts.
Flexible Containment for offloading drummed materials in a safe and efficient manner is provided by the Drum Transfer System (DTS) platform.
Used for lab scale and production operations at multiple International Pharma manufacturers, our Granulator containment technology applications take the idea of retrofits to another level.
Nutsche Filters are a mainstay in processing in the Pharmaceutical and Chemical industries. They typically function by keeping the slurry contents fluidized until most of the mother liquor is filtered through.
Process Area Barrier Curtains are a useful tool in improving the containment levels in existing installations and as a method to restrict access.
Our continuous liner system has been applied to production level V-Blenders. The low profile design was used in this application to support clearance limitations with this pre-installed piece of process equipment.
De-agglomeration of powder blocs according to GMP standard.
Thanks to its weighing terminal IT 9000 as well as its dosing device Multi-Dosimat, JetSolutions SA offers reliability and precision for filling powders or granulates into IBCs, boxes, bags, trucks, etc.
The DOSICON discharge station has been developed and patented by JetSolutions SA for discharging the DOSICON containers (IBC).
«IBC» means «Intermediate Bulk Container». An IBC is therefore a mobile, flexible and rapid storage device for any powder or granulates.
The DOSIMAT valve allows a precise dosing of any powder or granulate when filling drums, bags, boxes, big-bags, etc.
Dust-free bulk powder transfer from cardboard boxes, sacks or drums by means of a feed hopper with weighing frame. Positive raw material identification and registration by means of barcode scanners.
The PST system can be operated in batch or continuous way. A set of valves allows the discharge or the re-circulation of the mixture. The powder characteristics and the flow capability will define whether a longer sucking time is required.
The mixer is loaded with the individual raw materials exactly according to the formulation. The combination of Dosicon® weighing equipment with suction conveying units fulfils this task. Fundamental advanrages of JetSolutions automatic multi-component dosing are high dosing accuracy (for quantities ranging from a few hundred grams to several hundred kilos), the prevention of cross-contamination risks, and freedom from dust.
The negative pressure conveying is dedicated to small quantity of powder or granulates when:
The pneumatic POSITIVE pressure conveying (or PRESSURE conveying) is dedicated to the transfer of larger quantities of powder or granulates under following conditions:
A manual or automatic sampling valve can be adapted at the hopper or container powder outlet with a standard containment or bottle system.
The homogenizer is working as a particles size reducer for particles in suspension in a liquid and to calibrate their size at a defined value.
De-agglomeration of powder blocs according to GMP standard.
Thanks to its weighing terminal IT 9000 as well as its dosing device Multi-Dosimat, JetSolutions SA offers reliability and precision for filling powders or granulates into IBCs, boxes, bags, trucks, etc.
The DOSICON discharge station has been developed and patented by JetSolutions SA for discharging the DOSICON containers (IBC).
«IBC» means «Intermediate Bulk Container». An IBC is therefore a mobile, flexible and rapid storage device for any powder or granulates.
The DOSIMAT valve allows a precise dosing of any powder or granulate when filling drums, bags, boxes, big-bags, etc.
Dust-free bulk powder transfer from cardboard boxes, sacks or drums by means of a feed hopper with weighing frame. Positive raw material identification and registration by means of barcode scanners.
The PST system can be operated in batch or continuous way. A set of valves allows the discharge or the re-circulation of the mixture. The powder characteristics and the flow capability will define whether a longer sucking time is required.
The mixer is loaded with the individual raw materials exactly according to the formulation. The combination of Dosicon® weighing equipment with suction conveying units fulfils this task. Fundamental advanrages of JetSolutions automatic multi-component dosing are high dosing accuracy (for quantities ranging from a few hundred grams to several hundred kilos), the prevention of cross-contamination risks, and freedom from dust.
The negative pressure conveying is dedicated to small quantity of powder or granulates when:
The pneumatic POSITIVE pressure conveying (or PRESSURE conveying) is dedicated to the transfer of larger quantities of powder or granulates under following conditions:
A manual or automatic sampling valve can be adapted at the hopper or container powder outlet with a standard containment or bottle system.
The homogenizer is working as a particles size reducer for particles in suspension in a liquid and to calibrate their size at a defined value.
Guardian drum liners are an efficient and economical solution to the headache and expense of cleaning and/or disposing of used drums.
The clean room produced liners are designed for use in FIBCs, IBCs, corrugated boxes, bins or totes. The form fit design allows for a consistently complete fill and dispense of products because the liner has no pleats, folds or other traps to hinder material flow.
Guardian Form Fit Foil liners for hygroscopic dry bulk materials in FIBCs, IBCs and corrugated boxes improves package performance and protects.
Flexible Intermediate Bulk Containers, FIBCs or bulk bags are large woven polypropylene bags designed for storing and transporting dry flowable bulk products.
Buckhorn reusable intermediate bulk containers from Grayling Industries are designed to provide maximum product protection, hygiene, and efficiency.
The PaperIBC container from Grayling Industries is a dependable, economical and environmentally responsible alternative to drums, bottle-in-cage and other “heavy footprint” types of intermediate bulk containers.
Product containment and processing of small-scale lab operations can cause a headache if they are irregular or infrequently performed. A costly acquisition of a large-scale containment unit simply isn’t an option for many laboratory applications.
Our classic flexible film isolator that is popular in lots of laboratory settings.
The soloASEPTIC system has been designed to accommodate a variety of aseptic processes in a single-use disposable isolator. Allowing for flexibility in your facility this system works around your needs.
The all-rounder, star of the show. Ready to plug-and-play isolator for various applications in the pharma manufacturing process. Upgrade your existing plant to handle higher potency compounds and adapt to the changing marketplace.
Antibody Drug Conjugates (ADC’s) have become vital in the fight against many different types of cancer. The high potency nature of the toxin part of the ADC means you need to maintain the upmost operator safety while still running an efficient process. That’s why we developed the soloADC! Designed and manufactured in conjunction with an CDMO already handling the hazardous process, we developed this system which takes into all considerations when it comes to keeping both the people and products safe. With zero cleaning validation required the potential cost and time savings associated with cleaning validation are huge.
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.
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.
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?
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.
Two methods of containing blenders have been demonstrated. Included here are the use of flexible enclosures and separate, disposable powder transfer systems.
In this paper we explore how single-use containment technology impacts capital spending and operating expenses in these workflows.
In the containment world for OSD processing we see smaller batch sizes and more changeover, which require greater levels of efficacy, efficiency, and speed. Here we consider the pros and cons between a hard-wall system and a flexible-wall containment systems.
We review a full lifecycle safety structure that ensures the highest standards of operator protection from single-use flexible film containment systems.
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.
This white paper explores the advantages and disadvantages of lyophilization as well as lyophilizer solution examples and containment designs.
This webinar focuses on applications where flexible isolators have been used, including containment assessments to confirm performance and ergonomic benefits.
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 webinar will present best in class solutions to streamline the transfer process, resulting in more accurate and faster production and improved batch cycle times.
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.
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.
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.
The Sentinel Clear™ hood supports a broad range of pharmaceutical processing operations. The hood is designed for comfortable, non-encumbering use over long operating periods. When combined with the Sentinel XL™ PAPR blower and NIOSH-approved cartridges, it provides protection from airborne particulates, aerosols, and organic and acid gas vapors.
At ILC Dover we are always “creating what’s next” by listening carefully to our customers.
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
Product Sheet: G2Pac™
The DoverPac® continuous liner system provides the advantage of replacing packs without breaking containment, unlike using inflatable heads or having operators shuffle tube stock.
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 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.
ILC Dover, specializing in innovative single-use solutions for biotherapeutics and pharmaceutical processing, announced the launch of Water for Injection (WFI) for the biotherapeutics market.
Are you concerned about operational safety and efficiency during API manufacturing? This webinar discusses some of the common challenges faced in handling powders during HAPI/API manufacturing. Key strategies to mitigate risks associated with these issues will be shared including how flexible containment solutions can optimize powder handling during chemical synthesis.
ILC Dover LP, specializing in innovative single-use and chemical workflow solutions for biotherapeutics and pharmaceutical processing, announced plans to break ground on a new 90,000 sq ft manufacturing site located in Gliwice, Poland in response to continued strong growth within its life sciences business. The state-of-the-art facility equipped with 20,000 sq ft of ISO Class 7 cleanroom capability will manufacture initially single-use powder bags, single-use liquid bags, and single-use fluid transfer assemblies. The new site will provide redundant supply capabilities, reduce the lead times for its European and Asian customers and manufacturing will be consistent with the Company’s global quality system.
ILC Dover LP (“ILC Dover” or the “Company”), specializing in innovative single-use solutions for biotherapeutics and pharmaceutical processing, announced its launch of liquid single-use bioprocessing bags, representing the first of many new products for handling and supply of sterile liquids for the biotherapeutics market.
ILC Dover, Inc., a leading designer and manufacturer of high-performance materials for life critical and primarily life sciences-based applications, today announced the acquisition of KSE Scientific (“KSE”), a sterile solutions manufacturer which specializes in the production of Water for Injection (WFI) and related media and buffer solutions for biopharma, cell & gene therapy, tissue banking and medical device end-markets.
With the development of ILC Dover’s new Aseptic Isolator system new opportunities have opened up for many organizations who were previously able to conduct fill finish activities due to facility restraints or expensive closed barrier systems.
ILC Dover, Inc. (“ILC Dover” or the “Company”), a world leader in the design and production of single-use flexible solutions for pharmaceutical and biopharmaceutical manufacturing, today announced the acquisition of Solo Containment, Ltd. (“Solo”), a specialist manufacturer of flexible film isolators based in the United Kingdom. The acquisition will grow ILC Dover’s global pharmaceutical and biopharmaceutical business, expanding its solutions for high containment and powder transfer to include aseptic flexible isolators, among others.
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.