By Dec Group
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High containment and sterile materials handling solutions
Dec’s PTS Powder Transfer System® provides the base for a thoroughly engineered integrated system for safe handling and high containment of powders that include highly potent active pharmaceutical ingredients (HPAPIs).
Advantages include perfect control over toxicity and/or cGMP sterility requirements that form the basic challenges for many operations that require high containment facilities.
Dec Group provides cost effective and ergonomic containment solutions for any stage of the process from dispensing raw materials, contained processes and final packing steps. Elements include contained bulk handling and transfer, process isolation, contained sampling, toxic liquid and powder handling, dosing, mixing and dispensing solutions and process linking.
Compliance with OSHA and REACH standards
Increasing legislation and greater awareness of operator exposure risks have made effective containment a major concern in the pharmaceutical industry. Latest regulations defined by the US Occupational Safety and Health Administration (OSHA) and the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) guidelines clearly indicate that hazards must be tackled at source by means other than personal protective equipment (PPE) and should be accomplished as far as feasible by engineering-based control measures.
These and other regulations impose limits on exposure to any Substance of Very High Concern (SVHC), including highly potent active ingredients, category 1 or 2 carcinogen, mutagen or toxic to reproduction (CMR), persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) or other substances for which there is evidence of equivalent degree of concern (e.g. endocrine disruptors).
The REACH SVHC regime imposes specific controls on harmful over and above those that apply to other chemicals, while the European Chemical Agency’s (ECHA) “SVHC Roadmap” has placed “all relevant and currently known SVHCs” on its candidate list, amounting to many hundreds of substances.
High Containment Solutions
With a proven track record in managing highly technical and challenging isolation projects over 30 years Dec is the perfect partner for the integration of new or existing equipment by providing comprehensive safe, ergonomic and dedicated solutions achieving high containment down to the nanogram level.
Dec can offer precisely tailored solutions that meet a very wide range of applications from contained drum and bag filling or discharge into reactors to a fully contained micronizing suite for highly toxic and sterile products. These solutions cover the full range of process disciplines and challenges involved in pharmaceutical and fine chemicals manufacturing with many of Dec’s technologies, such as the PTS Powder Transfer System® being multi-role in addressing more than one need.
Dec’s integrated solutions include high containment and harmful materials handling systems, toxic liquid handling systems, process isolation (including filter dryer / tray dryer discharge, milling or micronizing isolators and rigid or flexible wall isolators), various containment facilities such as downflow booths, workbenches and mobile clean rooms, sterile and aseptic processes and nuclear containment gloveboxes, hot cells and radiopharmaceutical isolators.
Aseptic Filling Lines
Dec provides liquid & powder filling solutions for the pharmaceutical aseptic/sterile Fill-Finish process. From standard to custom-tailored equipment solutions Dec‘s engineered microdosing and containment system technologies are designed to meet very specific customer needs for sterile primary packaging.
Dec‘s filling solutions are cGMP compliant, perfectly adapted to the process requirements and accurately designed to comply with the most recent revisions of the Annex 1 Manufacture of Sterile Medicinal Products guidelines.
DecFill® equipment is configured for a seamless integration into customer production lines and designed to accommodate various speeds and containers, including ready-to-use (RTU) and ready-to-fill (RTF) bottles, vials, cartridges, syringes, pre-sterile nested trays and combined powder and liquid filling for dual chamber systems.
Filling methods for liquids/gels include BoMa technology, net weight filling, peristaltic pump, or rotary piston pump while microdosing technologies for powder include μPTS, flexPTS, sPTS, and Auger system.
For government and radiopharmaceutical markets, there are occasional needs to handle radioactive material in safely contained ways. Such nuclear containment solutions need to meet the Nuclear Quality Assurance (NQA-1) standards defined by The American Society of Mechanical Engineers (ASME) in its ASME 2008:2009 Addenda.
Dec Group nuclear containment solutions include stainless steel gloveboxes and isolators manufactured by group member Extract Technology (Walker Barrier Systems), a leading expert in radiological materials handling systems for the nuclear, pharmaceutical, biotech and radiopharmaceutical industries.
Click on High containment integrated systems for other information.
Click on Dec containment solutions for products overview.
Click on Contained aseptic filling for further information.
Click on Process Isolation to OEB 7 standards for further information.
Click on Toxic liquids handling for further information.
Click on Contained materials handling for further information.
Click on GMP sterile manufacturing for further information.
Click on Nuclear Containment for further information.