Isolators ensure the highest level of protection for the operator, product and environment and are suitable for handling the most dangerous substances or protect most sensitive process. Operator and process are separated by physical barrier and controlled pressure inside Isolator. Environment protection is assured by exhaust air HEPA filtration. Product protection is assured with inlet air HEPA filtration, physical barrier between operator and process and controlled atmosphere inside isolator.
Our experiences in isolator development and manufacturing technology allow us to offer isolators which will provide safe and sterile work environments for manipulation with hazardous/sterile materials. Isolators are intended for packaging, sieving, sampling, weighing and other manipulations of pharmaceutical materials under certain conditions (sterile, inert atmosphere,… ) or work with hazardous (microbiological, OEB3, OEB4, OEB5) materials.
Our isolators offer innovative solutions in material transfer in/from working chamber, without braking conditions inside the isolator. According to different sizes and shapes of inlet/outlet packaging, we have developed multiple solutions (multiple drum ports, CLS ports, pass through chambers, pressure equalizing chambers…), which assure efficient transfer of used packages.
Working chambers are made of stainless steel quality 316L with surface roughness upon request (brushed, polished…). All corners of working chamber have suitable radius that enable easy cleaning. Working chamber design enables operator to reach all corners with gloves (for cleaning) and has all equipment on desired place. Front glass with typical 8° inclination from vertical assures comfortable working position. The glass is made of tempered safety glass and is hermetically sealed to working chamber. Gloves are placed on elliptical openings on front glass - glove is changed without opening isolator to environment. Systems typically allow safe glove and filter change.
Isolators are typically controlled through HMI which is located on easy accessible location. On the main screen of the panel basic parameters, process quantities and regime of machine, which make machine easy to use, are given. For a more detailed view on machine functioning are foreseen quickly accessible screens like P&I scheme of machine, Trends of process quantities … The control system assures reliable maintenance of required conditions, safety of operator, process and environment and compliance with EU and US regulations (CFR part 11). All critical process quantities (P, T, Rh, H2O2 concentration, H2O2 consumption and remaining quantity, air velocity inside chamber…), can be monitored on HMI and report can be printed. In case of inappropriate conditions, alarms are triggered, shown on HMI and written in report.
In cooperation with the customer we develop different types of isolators, regarding customers needs and requirements (sampling, weighing, dispensing, sterility testing…). Dimension, shape, number of gloves, additional equipment, and atmosphere is adjusted to planned work and are finally determined on real size steel MOCK UP model. With our experience we can offer equipment, which will be the most suitable solution for customer’s needs.
- VHP sterilization system
- ATEX execution
- Particle counter
- Microbiological air sampler
- Specific atmosphere controls (T, Rh, O2…)
- Spray gun
- Weighing scales
- Equipment for supervision and control of weighing process
- Welding tongs - Device for sealing bags
- Glove testers
- Shelve holders
- Safe waste removal - Continuous liner system (CLS) or DTPE port
- Lifting system
- Drum clamping and tilting mechanism
- Needle for purging with nitrogen
- Platform for operator
- Zip bag system