Dec Group GMP Aseptic Manufacturing Solutions

Dec Group has developed a comprehensive range of solutions for cGMP sterile manufacturing processes, including material transfer, powder sterilization, blending and mixing, micronization, isolated processes and integrated applications.

Most of these solutions take advantage of the PTS Powder Transfer System® (PTS) ability to move powders and liquids over distance under total containment. Furthermore, PTS is designed according to the latest cGMP requirements without inaccessible areas.

Aseptic manufacturing challenges

The Pharmaceutical Industry has steadily moved to increased production and handling of sterile highly potent active ingredients (HPAPIs) within multi-purpose designed plants.

All of Dec’s containment technologies and systems comply with pharmaceutical quality manufacturing standards and are available for aseptic operations. These can be easily integrated into existing production lines. The key challenge in GMP sterile manufacturing is to prevent product contamination at all stages of the process.

Recent years have shown steady increase in demand for ultra-sterile and highly potent products across the pharmaceutical value chain. These include antibiotics for intravenous or intramuscular injection in powder form, IV preparations, plasma fractionations and other products that need to be produced under sterile conditions.

New EU/FDA legislation outlawing irradiation of products makes it even more crucial to be able to guarantee sterility in the original manufacturing of powders and other materials since it is now more difficult to sterilize them post-production.

Non-compliant facilities still using open aseptic processing systems (including restricted-access barrier system (RABS) clean air protection are not able to ensure consistent contamination prevention. To prevent major and persistent risk of sporadic contamination, it is strongly recommended to run a fully closed or contained operation under strictly controlled conditions.

Hygienic Transferring with CIP cleaning attachment

PTS transfer bodies and hoses can be cleaned in place using the PTS Cleaning Device, allowing CIP/SIP to be easily achieved.

The system is fitted with a liquid separator installed on the upper part of the PTS body that sucks liquids into the system while a float in the cover prevents the liquid from entering into the vacuum line. At the same time both the PTS body and the transfer hose are cleaned internally in ways not possible merely using a spray nozzle.

The system can be cleaned in line along with other process equipment and is dried automatically by using vacuum hence avoiding the need of hot air supply. Additional spray nozzles are used in case of non-soluble or very sticky products.

The PTS system can be used under cGMP sterile conditions. From charging powder into multiple vessels for intravenous solution preparation (IV) to handling powder under sterile conditions for injectables, the system guarantees powder integrity during the transfer as well as complete and validated cleaning and sterilization.

Due to its unique flat filtration concept, the system can be sanitized or sterilized with either 90 °C hot water or steam. The stainless steel membrane can be cleaned and sterilized in situ preventing the opening of the system after sterilization.

VSV Powder Sterilization

Preventing microorganism contamination of food or nutritional powders is a demanding challenge still to be fully addressed by the industry. The demand for solutions is made even more urgent by increasing demand for ingredients with extended shelf life and greater diversity.

The key to the solution is to avoid or eliminate any contamination during the powder processing in bulk material manufacturing facilities.

In cooperation with ETH Zurich and industrial partners, Dec has developed an innovative solution to decontaminate heat sensitive powders by using steam and vacuum. This innovative technology uses short term exposure to Vacuum-Steam-Vacuum (VSV) treatment to achieve microbial inactivation without altering the powder properties. This technology shows much better results than the High-Temperature Short-Time (HTST) treatment used for liquids, which is less effective for powder decontamination due to the difficulties in reaching the microorganisms in the porous surfaces of solid food.

Dec can supply the complete process line from handling the contaminated material, powder decontamination and final packing under controlled atmosphere. Its dedicated test facility is fully equipped with a pilot unit allowing to validate the microbial log reduction and any powder property changes during the treatment.

Blending/Mixing

PTS Batchmixer® achieves fully sterile blending or mixing by being fully contained throughout the process with no requirement for disconnection at any stage of the operation. PTS Batchmixer® is usually integrated in a process line in a closed way by flexible lines and can be cleaned and sterilized in line with the upstream and downstream equipment.

Designed according to the latest cGMP requirements, PTS Batchmixer® has no internal moving parts or inaccessible areas allowing the system to be sanitized or sterilized with either 90°C hot water or steam.

The system is equipped with various temperature probes for temperature mapping as well as a steam trap valve at the lowest part of the mixer. The vessel is insulated to prevent a direct contact with the vessel wall and keeping heat loss as low as possible.

An MPTS  Sampling device can be added to allow sterile inline sampling to be performed during blending without potential sterility breach.

Micronizing/Milling

The patented 4th generation MC DecJet® isolators provide full OEB-7 level containment of highly active and/or sterile compounds thus offering both operator and product protection. The MC DecJet® range of fully-contained micronizing machines, from MC DecJet® 30 to MC DecJet® 400, combine years of experience in micronizing and containment technologies to provide critical process safety and an ideal relationship between micronizing process and environmental control.

Isolators can be designed either as flexible, semi-rigid or rigid wall systems,  fully modular allowing for  the integration of a Co-mill for pre-milling the materials or interchangeability between various MC DecJet® sizes or different types of mills such as universal machines.

Isolator technology

Dec has designed various sterile isolator solutions with specific control over potential contamination sources. In particular they eliminate the need for operator intervention, the highest risk cause of contamination.

To ensure a high Sterility Assurance Level, the isolator is biologically decontaminated with VHP (Vaporized Hydrogen Peroxide) and the process equipment is sterilized with steam.

Depending on process requirements, Dec can provide both turbulent and laminar air flow isolator systems. Turbulent air flow comes in where the positive differential pressure and clean, i.e. aseptic condition and/or safe environment are maintained by using a forced ventilation system, mostly applied when handling powder with a risk of dust creation.

Unidirectional airflow systems ensure that particles are rapidly swept away from critical areas. It is therefore appropriate to use unidirectional flow in processes where mechanical equipment or material handling within the isolator produces particles which could contaminate the process, e.g. liquid filling.

Dec has also developed a unique solution by using the PTS® to interface in a fully sealed way various process equipment and isolator systems eliminating any risk of loss of sterility.

Sterility Testing Isolators

S-Test range systems are specifically designed to allow for sterility testing in an aseptic environment. They are ideally suited to laboratories or where space is limited. They can be placed either adjacent to or incorporated in production lines in order to allow integrated process testing.

Fully integrated VHP systems can communicate with the isolator’s PLC allowing for aseptic processing and decontamination as well as sterilization cycle management including aeration control to help with the removal of the VHP after the sterilization cycle. Once sterile, the samples can be membrane filter tested on the optionally integrated Millipore® Steritest system or Sartorius Sterisart®NF Units. Waste materials can be removed via the RTP or via the visor at the end of Testing procedure.

Dec’s S-Test systems include tailor-made versions ranging from soft wall short term to solid wall long term use systems. They can feature continuous particle monitoring and airborne biological sampling methods.

Resources

Click on Aseptic Process to download product sheet.