ABOUT DEC GROUP

Dec is a leading global provider of contained powder handling systems and is recognized as a world-leading expert in process containment technologies. It has been supplying the pharmaceutical, chemical, food and cosmetic industries for more than 30 years.

Headquartered near Lausanne, Switzerland, Dec has a global presence with subsidiaries and agents in over 30 countries including subsidiaries in the UK, Ireland, Germany, Poland, the Netherlands, India, China and the USA.

In excess of 600 companies worldwide have successfully integrated more than 9000 Dec systems into their production sites. These include a wide range of patented products that enhance safety, hygiene, containment, reliability and productivity.

Dec offers innovative concepts and solutions across the range of powder handling and process containment applications, including bulk handling, pneumatic transfer, micronization/milling, sampling, blending, dosing, aseptic handling and fill/finish solutions, process isolators, advanced cleaning (CIP/SIP) features, serialization and secondary packaging solutions.

FEATURED PRODUCTS

Dec’s aseptic filling equipment is configured for a seamless integration into existing production lines and designed to accommodate various containers, including sterile RTU / RTF (ready to use or fill) bottles, vials, cartridges, pre-fillable syringes and Dual Chamber Systems (DCS).

The patented DCS® pharmaceutical Drum Containment System is a stainless steel cylindrical glove box with a glass cover and two glove ports. Highly economical in comparison with conventional isolation systems, DCS® ensures precise, contamination free emptying of drums providing high containment (< 1 µg/m3).

The systems can be provided in sterile, toxic or sterile toxic arrangements with the great advantage of being 100 % scalable.

Lyophilization processes require quality design and high performance containment systems. Dec also offers automated solutions for loading and unloading freeze-drying systems.

Active pharmaceutical ingredient (API) manufacturing requires powder handling in a GMP and contained manner. Similar to chemical manufacturing, operations like charging powders into a chemical reactor, emptying a centrifuge or charging and discharging a dryer are standard processes.

From the incoming materials handling to the final packaging, Dec offers efficient and reliable solutions without altering product characteristics and adapted to specific containment needs.

Dec‘s philosophy is to develop customer-specific modules and equipment. Starting with agreed project scope, intensive brainstorm sessions, strong design processes and (customer) reviews, the aim is to deliver an innovative filling solution. During the concept development, risk analysis is an important tool in the decision-making process.

Traditional vials, ampoules, and cartridges are still the most popular delivery systems and the prefilled syringes are still experiencing the greatest growth in the market of any parenteral dosage form. Therefore, to advance the development program appropriately, pharmaceutical R&D scientists should effectively leverage the advantages offered by each form of packaging and dosage.

The aseptic/sterile Fill-Finish equipment solutions need to be cGMP compliant, dependable and accurately designed to comply with the most recent revisions of the “Annex 1 Manufacture of Sterile Medicinal Products guidelines”. Newly designed equipment needs to accommodate for small batches, various speeds and containers, including RTU / RTF (Ready To Use or Ready To Fill) bottles, vials, cartridges, syringes and pre-sterile nested trays. Moreover, the filling equipment solution should also improve the ergonomic use for operators and maximize cleanroom efficiency.

In pharmaceutical manufacturing containment performance is critical to minimize operator exposure and process cross contamination.

Secondary pharmaceutical manufacturing typically includes the final formulation, so the need to meet current Good Manufacturing Practice (cGMP) regulations and quality standards are paramount.

Recent years have shown steady growth in manufacturing sterile, high potent products in the pharmaceutical industry. Antibiotics for intravenous or intramuscular injection in powder form such as Ceftriaxone Sodium for example, need to be produced under sterile conditions.

Batch manufacturing is still commonplace in the pharmaceutical and chemical industry. Such operations require to use intermediate packaging for product storage between each process step leading to numerous disadvantages such as low production flexibility, process downtime, high risks of operator exposure, product contamination and sterility loss.

Particle size reduction is a key process in laboratories and small scale manufacturing, right through to full size production.

If you handle multiple packaging, Dec can help in providing one single multi-packaging filling station handling FIBCs, drums, cardboard boxes etc.).

Dec provide custom designed isolators for dispensing and/or sampling from various containers such as bags and drums into intermediate packaging or for direct charging into process equipment. These systems offer high containment and a controlled environment offering fast cleaning and drying features allowing for swift product changes.

Dec provides unique solutions to charge process equipment such as reactors, mixing vessels or dryers in a fully safe manner eliminating the need to connect the isolator directly to the equipment to be charged or to install the isolator on an upper floor. A single isolator system can be used for multiple vessels charging.

The pharmaceutical OSD manufacturing sector typically includes the final formulation to produce tablets and capsules, so the need to meet the current Good Manufacturing Practice (cGMP) regulations and quality standards is paramount.

Mixing powder is a complex process and the final results will strongly depend on the material properties and the selected type of mixer.

DCS® Liquid was specifically developed for toxic and corrosive liquids, achieving containment levels of < 1 ppb. The safe and contained emptying and filling of drums is thus made possible without additional precautions, such as full protective clothing or large laminar airflow booths.

BoMa systems allow transferring and dosing products with a complex rheology, in particular products of high viscosity. The absence of rotating seals is ideal for its use for aggressive or flammable products.

For highly accurate and controlled filling and weighing of sterile liquids, our proven and reliable technology prevents costly overfilling. The easy to validate aseptic filling machines are compatible with all high-tech production facility equipment, software and processes known in the pharmaceutical primary packaging industry.

Dec has designed a wide range of versatile and low cost flexible containment solutions such as disposable glove bags, complete flexible enclosures and semi-rigid isolators suitable for many operations whether it be formulation plants including dispensing and granulation or around tablet pressing machines for both R&D and production facilities.

Inno4Life, part of the Dec Group, has in-depth knowledge and containment equipment solutions for the aseptic/sterile Fill-Finish pharmaceutical industry. In line with ISO 14644, including monitoring of viable and non-viable monitoring to comply with the most recent revisions of the ISPE containment specifications cGMP and GAMP5 guidelines.

Dec can provide complete solutions from the filling of primary packaging to secondary packaging including serialization and tracking.

Dec offers pharmaceutical filling lines for both liquids and solids for the aseptic fill-finish process that require high containment equipment.

Dec’s ability to provide end-to-end solutions from API manufacturing to primary packaging filling covers the complete range from R&D processes and small batches to large filling campaigns. Our solutions include state of the art robotics for the filling and handling of complex delivery systems like pre-filled syringes (PFS).

Isotube is an effective option for the safe loading and charging of multiple drums of HPAPIs.  Compared to the DCS® Drum Containment System for safely discharging drums, it is the preferred choice when charging lumpy and agglomerated products as a lump breaker system can be included in the lower part of the discharge hopper.

Intermediate Bulk Containers (IBCs) are still widely used in the pharmaceutical industry for instance in oral solid dosage manufacturing.

Dec excels in providing comprehensive technical solutions for packing powders into bags and drums from process equipment discharge such as a dryer or a mixer, milling and dispensing to the final packing of the product.

If you are looking for filling systems for different products such as liquids, powder or flow-resistant highly viscous materials, Dec provides a modular concept allowing to meet a variety of packaging that is appropriate in the field of research and development as well as clinical trials. Speed up your go-to-market strategy with innovation and modular thinking.

UMS DecMill provides the ultimate in flexibility, taking up the minimum area for the maximum product recovery. The mill is very versatile and can be adapted according to various customer requirements. From a turbine to a pin disk, the mill can be easily configurated to achieve the desired particle size.

The patented Transbatch system relies on modern technology to safely convey and dose granules and other solids under critical installation conditions in terms of both transfer length and height.

The patented PFL Powderflex provides continuous and precise dosing of small to medium quantities of powder, whether the requirement is for controlled charging of powders into continuous production processes or for predetermined precision dosing.

Lyophilization processes require quality design and high performance containment systems. Dec also offers automated solutions for loading and unloading freeze-drying systems.

The systems can be provided in sterile, toxic or sterile toxic arrangements.

The systems can be provided in sterile, toxic or sterile toxic arrangements with the great advantage of being 100% scalable.

Dec Group specialists offer full support for the integration of the serialization process into the pharma industry supply chain.

Dec offers filling lines for both liquids and solids for the aseptic fill-finish process that require high containment equipment.

The patented PTS Batchmixer® allows to mix powders with different characteristics in a contained environment while reducing overall process times compared to traditional systems. With industrial applications from 2 to 6000 liters, the system also enables the operator to vary product volumes from 10 to 100%.

The production and handling of highly potent sterile APIs within a multi-purpose designed plant are becoming more and more prevalent within the pharmaceutical industry.

Over many years, Dec has acquired recognized expertise in designing and supplying an extensive range of isolators enclosing a mill or a MC DecJet® spiral jet mill for either individual or combined operation.

Dec provide custom designed isolators for dispensing and/or sampling from various containers such as bags and drums into intermediate packagings or for direct charging into process equipment. These systems offer high containment and a controlled environment offering fast cleaning and drying features allowing for swift product changes.

PTS Powder Transfer System® challenges convention by using both vacuum and pressure to move powders as if they were liquids. This eliminates the need for gravity charging and therefore making multi floor processes a requirement of the past.

At Extract Technology we believe there are five questions you need to ask yourself before purchasing a high potency containment or isolator system. Creating a safe environment for people working with highly potent substances is not an easy task. It’s not just a matter of buying a readily made solution.

Restricted Access Barriers (RABs) were developed to enhance pharmaceutical aseptic processes carried out in conventional clean rooms. Extract Technology customer RABs are designed to fully comply with our customers’ requirements for aseptic pharmaceutical processing.

Providing a suitable cGMP environment for operators to perform either sampling or dispensing tasks in a safe and comfortable atmosphere, the ETL facilities are high class state of the art piece of equipment. Complete with material and personnel airlocks and a downflow booth, the facility operates with a positive pressure to aid in achieving a clean cGMP environment.

Extract Technology integrated the necessary viable and non-viable particle monitoring within the machine along with the use of a 21CFRPart 11 validated paperless (touch screen) chart recorder to enable the customer to review each stage of the cycle in full detail.

Extract Technology’s Cell Therapy Isolators are designed to provide an ergonomic and practical alternative to traditional clean rooms for stringent cGMP and international regulations for the production of cells for clinical use.

As part of the standardised product range, Extract Technology’s Mobile Automated Glove Tester provides an effective means of a controlled automated pressure test of gauntlets and cuffed assemblies.

Extract Technology are a leading worldwide supplier of rigid and flexible containment systems for the pharmaceutical healthcare, biotech and chemical markets.

Extract Technology are a leading worldwide supplier of containment and aseptic systems for the pharmaceutical, healthcare, biotech and chemical markets.

Complete containment solutions based around an innovative range of Downflow Containment Booths bring different features and benefits to your application. But all have one thing in common: they provide a Guaranteed Working Environment.

Extract Technology's self-contained, ready-to-use design provides functional clean room space wherever and whenever it's needed. Whether the need is to expand manufacturing, R&D or processing capacity at an existing facility, a remote location, or around the globe, the company's MCRs can be transported and fully operational more rapidly than other clean room options.

Extract Technology aseptic isolators are designed to allow operators to perform aseptic processes in a sterile environment providing assurance of process integrity.

The Extract Technology, formerly Walker Barrier Systems, Square Tray Dryer-Filter Isolator is designed to give total operator and environmental protection during potent API slurry filtration, drying and product transfer between the dryer and the receiving container.

The Extract Technology Milling Interface Isolator is designed to enable operators to manipulate and mill hazardous materials in a contained manner, protecting both the operator and the surrounding environment.

The Extract Technology, formerly Walker Barrier Systems, Half-suit Isolator is designed to allow operators to perform sterility testing in an aseptic environment providing assurance of material integrity. Benefits of a half-suit in combination with or without a Transfer Isolator provide higher levels of ergonomic comfort for large volumes of sterility testing.

The Extract Technology, formerly Walker Barrier Systems, small scale Filling Machine Isolator is designed to enclose the filling, stoppering and capping operations of a Powder or Liquid Filling Machine while providing an Aseptic environment for the process. Featuring unidirectional airflow, hinged "easy-lift" window panels and special "mouse hole" for the exit of filled vials.

Flexible Containment Isolators provide containment standards better than can be achieved with Downflow Booth technology, and often compare favorably with a Rigid Isolator system.

The Extract Technology , formerly Walker Barrier Systems Filter/Tray Dryer Isolator is designed to give total operator and environmental protection during potent API slurry filtration, drying and product transfer between the dryer and the receiving container.

Extract Technology, formerly Walker Barrier Systems, designs and builds custom Pharmaceutical isolators for aseptic product testing, processing and filling. This includes integration with filling machines, freeze dryers, autoclaves and decontamination systems.

The Clean Air Barrier Isolator by Extract Technology, formerly Walker Barrier Systems, is a new isolator concept which provides standard features for laboratory use in a cost friendly package.

The Extract Technology Booths are used extensively in the pharmaceutical industry to safeguard operators against harmful dusts generated during many manual powder handling operations. Clean air from the ceiling plenum is distributed evenly across the whole of the work area pushing any respirable dust generated downward and away from the operators breathing zone.

CONTACT INFORMATION

Dec Group

1118 Industrial Pkwy.

Brick, NJ 08724

UNITED STATES

Phone: (732) 202-7536

Contact: Andrew Milner

FEATURED ARTICLES

  • Earlier today, The Dec Group completed the acquisition of the Extract Technology business from US based Wabash National Corporation, a US listed company (NYSE: WNC).

  • Powder handling and high containment specialists Dec Group has announced the appointment of Intrepid Bioprocess Technologies as their US agent for the Westcoast including California, Oregon and Washington.

  • Although most current legislations concerning traceability of pharmaceutical products focus on serialization rather than aggregation, the latter is an essential component of internal and external traceability of your products. Aggregation is the logical next step as well as the next business opportunity, as it vastly increases efficiency throughout the pharmaceutical supply chain.

  • Primary packaging of pharmaceutical products often involves filling containers (including vials, syringes and bottles) with powders and/ or liquid solutions. Manufacturing staff, equipment and premises are all subject to stringent quality controls – and for good reason: patient safety. This document intends to provide information on the latest status, trends and technologies in parenteral filling equipment.

  • Dec will participate in the 2020 PDA Universe of Pre-Filled Syringes and Injection Devices event held October 5 – 8. This year's conference will be held virtually. It offers industry expertise by sharing new developments and trends in this continuously growing market while also reflecting on regulatory matters and common challenges.

  • Over more than three decades, Dec Group has brought innovation to the pharmaceutical process industry by introducing active versus gravity charging and process linking with its Powder Transfer System (PTS), a unique solution that uses both pressure and vacuum to ensure all forms of dry powders and granules flow efficiently and safely between processes and containers.

  • Due to the high potency of the pharmaceutical active ingredients (APIs), machine operators have to be protected and while at the same time, humans are a high source for product contamination. In pharmaceutical manufacturing facilities, isolators are becoming increasingly important as they can achieve the desired level of protection and security. This article presents a fully integrated highly complex isolator and process equipment solution offering high safety, efficient control and cleaning features as well as full compliance in terms of manufacturing regulations.

  • A customer had planned a new facility for the production of intravenous liquids. They were facing a challenge of charging multiple vessels with salt, glucose and active carbon under controlled conditions achieving high accuracy. See what solution allowed them to create a highly automated high capacity facility.

  • A facility handled sterile blending and packing powder from a tilting filter dryer under sterile conditions. They were transferring the discharge of the tilting dryer by screw feeder and transferring into an agitated mixer. Discharging the mixer by a screw feeder into a packing system. They were encountering sterility loss through mechanical seals and docking of the dryer to the screw feeder and difficulties to clean and sterilize the system in place. A solution was a full automatice system including a transfer system, batchmixer and sampling device.

  • An operation required manual filling of IBCs by using a flexible isolator installed on an upper floor with large amounts of excipients (lactose and micro cellulose)> 100 kg and only a small amount of APls of a few kilos. Operation was strenuous due to the large quantity of excipients to be handled in the isolator which lead to the damage of the flexible isolator and containment breach. Several equipment and process changes allowed them to see an increase of plant productivity.

  • A multipurpose facility for API production had various requirements including milling, micronizing, packaging and the possibility to blend various batches together before or after milling. A set of material handling products from Dec Group was the solution.

  • Powder handling plays a major role in the design and the operation of an API facility, and can often become the “bottle neck” of the plant. The constantly increasing toxicity and reactivity of products in recent years as well as the ever more demanding production standards with regard to quality have made closed powder handling an unavoidable factor and manual handling obsolete. Selecting a suitable technology has become vital for the development of a project since it can largely influence the entire design.

  • By reviewing and evaluating the health and safety data for each product involved in the manufacturing process this supplier was able to determine that the correct containment solution.

  • Cell and gene therapies are currently produced in fixed facilities that require a significant upfront investment. Modular concepts offer an opportunity to shift from these large, fixed assets.

  • The move from sterility testing within LAF safety cabinets to those in aseptic isolators has resulted in a marked decrease in false positives.

  • To allow a pharma facility to maintain regulatory compliance with ISO 5 conditions ensuring product protection, a positive to ambient pressure regime was used within the airlocks.

  • As isolators become more customized to meet the requirements of specific Pharmaceutical processes, the controls systems have been challenged to provide more safety and flexibility. By Walker Barrier Systems

  • Uses of isolators for aseptic processing are far reaching. The earliest use of aseptic isolators were for sterility testing. Sterility test isolators make up most of aseptic isolator use and are available in many different sizes and configurations.

  • These days several Pharmaceutical companies are moving to single use, flexible film isolators for containment of potent compounds during Pharmaceutical processing. Flexible film isolators have also been used for aseptic processes, like sterility testing.

  • While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier.

  • This document provides an overview on how to properly validate sterility test isolator systems and then, via a case study, describes a strategy for streamlining the validation process when equivalent isolators and/or generators are installed in a sterility test suite. By James R. Rickloff, Partner/Scientific Director Advanced Barrier Concepts, Inc.

VIDEOS/WEBINARS

  • This video highlights Dec’s high containment micronizing technology and materials handling systems. See how a complex two-floor large scale high containment micronizing plant equipped with fully contained sampling and pack-off technology solutions ensure OEL levels are kept well under the target while allowing fully streamlined processes.

  • The trend towards pre-filled disposable syringes whether of the single or dual chamber type is increasing. This webcast concentrates on the aseptic pharmaceutical packaging process challenges that need to be addressed in the final filling process of dual chamber syringes, where both liquid and powdery substances are mixed by the patient immediately prior to injection. This practice shows clear advantages as it can eliminate preservatives needs while enabling longer shelf lives.

  • This online event will give you the opportunity to gain insight on process innovation, occupational health and safety questions and appropriate technologies available today to overcome the many challenges in high containment manufacturing facilities. The handling of HPAPIs is a highly complex process and calls for sophisticated equipment and process isolators. Dec offers comprehensive solutions for R&D teams to production plants.

  • With the COVID-19 pandemic’s effect on pharmaceutical supply chains, boosting local active pharmaceutical ingredients manufacturing and ensuring domestic drug production needs to be actively supported. But how to quickly implement a new state-of-the-art modular high potency pharmaceutical manufacturing plant and taking the opportunity to integrate the latest patient delivery systems?

  • Dec Group is your partner in powder handling and process contamination technologies. With locations around the globe we have over 30 year of experience in contained and sterile powder handling solutions. This video highlights our capabilities and our state-of-the-art solutions for sophisticated risk management.- Dec Group is your partner in powder handling and process contamination technologies. With locations around the globe we have over 30 year of experience in contained and sterile powder handling solutions. This video highlights our capabilities and our state-of-the-art solutions for sophisticated risk management.