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.
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. Dec has designed various sterile isolator solutions with specific control over potential contamination sources. Operator intervention, which is the most frequent contamination cause, is eliminated.
To ensure the 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
Micronization and Packing
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 furthermore developed a unique solution by using the PTS Powder Transfer System® to interface in a fully sealed way various process equipment and isolators system eliminating any risk of loss of sterility.
Sterility Test Isolators
S-Test range systems are specifically designed to allow for sterility testing in an aseptic environment.
Fully integrated VHP systems are able to 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 are available in a number of standard formats as well as 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.
These isolators 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.
Standard Product Line
SteriPharm® is a user and maintenance friendly system providing a cost effective alternative solution for aseptic processing or sterility testing.
Available in two standard sizes, SteriPharm® is designed to offer increased protection and quality assurance of process integrity by utilising singe pass turbulent flow ideal for sterility testing or recirculatory unidirectional airflow for aseptic manufacturing process (achieving a Grade A / Iso 5 environment)
Modular Cell Therapy Isolators
Alternative to traditional clean rooms for stringent cGMP
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.
Isolator systems will be custom designed to suit individual customer requirements but will generally include the following:
Ergonomic design generated with the aid of full scale mock-ups
Multiple chamber arrangements providing defined barriers between process steps, enhancing aseptic performance
Fully welded fabrications of 316L stainless steel, providing crevice free construction with internally radiused corners
On-board recirculation laminar flow are flow system guaranteeing Grade A /ISO 5 classification
Integration of proprietary devices e.g. RTP’s incubators, centrifuge and decontamination system etc.
Integrated viable / non-viable systems
Cell Therapy Isolators - Design Advantages
Main advantages of Cell Therapy Isolator compared to traditional Cleanroom operation:
cGMP compliant design
Increased sterility by reducing contamination risks (increased patient safety)
Smaller operational space
Reduced human interventions
Physical barrier and pressure differential
Hydrogen peroxide decontamination
Highly controller material flow
Full process equipment integration within grade A / ISO 5 environment
Easier process separation (dedicated chambers)
Different pressure regimes available within each chamber
Full gowning not required
Continuous particle monitoring system
Hydrogen peroxide vapour generator integration
Automated multiple glove tester
RTP (Rapid Transfer Port)