The Standard Group of Companies is a leading supplier of equipment in the chemical and pharmaceutical industry.
A key and pivotal part in these manufacturing operations is “Containment”
The Schematic Engineering Industries division specialise in many pieces of equipment which compliment and support all containment activities.
The 3 main types of containment solutions provided by the Schematic Engineering Industries division include: -
- Barrier isolators
- Glove boxes
- Pass boxes
The simplistic understanding of containment in the pharmaceutical industry is based on the following logic.
All pharmaceutical operations involves 3 key elements:-
- The process media
- The operator
- The surrounding environment
The actual containment is successful when the 1st product (process media) can be successfully isolated from the other 2 elements.
The manufacture of highly active and dangerous pharmaceutical substances involves an interaction between 2 threshold values.
This includes the PDE (permitted daily exposure) which in turn is used to calculate the occupational exposure limit (OEL).
The OEL limits range from 1 to 5 with 5 being the most aggressive and potentially dangerous.
In addition to these threshold values, a risk assessment of the overall process and the associated containment transfer systems including the cleaning are key.
The Standard Group pay particular attention to providing barrier isolators or glove boxes which will provide the maximum level of protection against the risk of product contamination and employee safety.
The reason why minimum contamination is successful is the isolator physically isolates the critical area and uses automated transfer systems to maintain sterility at all times.
The Schematic Engineering Industries department can provide “rigid” and “flexible” isolators to bespoke customer requirements.
Flexible isolators can be classed as a single use isolation system but has the following advantages:-
- Single-use means no cleaning required
- Cleaning SOPs and validation not required
- Easily movable if needed
- No maintenance
- 70-80% less costly than hard wall systems
- Ergonomically adaptable to all operators’ body sizes
- No cross contamination from previous production
Operational benefits of rigid barrier isolators include: -
- Stable and accurate results
- Clear visibility during operation and cleaning
- Full Operator safety - fully interlocked air-locks, doors and visors
- Uncontaminated process media
- cGAMP - Alarms and safety measures in case of breach
- Automated Operation - reduced operator error likelihood
As containment is one of the most critical parts of any pharmaceutical process, it is very important for suppliers to be able to support a fully integrated system with third party equipment.
The Standard Group can do this but are also able to provide a full turnkey solution based on specific customer requirements.
Typical applications where containment is required in the pharmaceutical industry include: -
- Sterility testing
- Sterile loading and unloading of vials
- Sterile Compactor, Granulators and filling lines
- Aseptic and Asepsis processes
- Capping & Sealing Lypholizer (Freeze Drying) Isolator
For more information click here or contact our UK and Indian offices.