Becto’flex Containment Systems Pvt. Ltd. is an engineering company specialising in the design, supply and application of flexible containment and integrated containment systems. The company has become a leader in this field for all aspects for the containment of potent materials in the pharmaceutical, chemical and food industries.
Becto’flex evaluates current production lines and provides solutions, both physical and procedural, to ensure a clean and safe working environment and a higher GMP standard for its customers' facilities. Our speciality is designing and retrofitting existing facilities with flexible isolators and working with equipment suppliers to improve the containment on new equipment.
Flexible containment systems:
By applying proven methods of flexible containment we can offer a way forward that will improve your equipment capability for an ever increasing containment standard and reducing investment. The upgrading of existing facilities with flexible containment systems has many advantages for clients, including:
Becto’flex speciality is designing and retrofitting existing facilities with flexible isolators in order to enable clients to carry out their daily duties in a contained and safe manner. These flexible isolators fully contain the following operations: sampling, seeding, filter change outs, product charging, heel removals, seal cleaning, valve removals, etc.
Becto’flex can supply containment rooms, airlocks or flexible curtains to aid segregation of equipment or plant. The containment rooms and airlocks can be designed either fully flexible or semi solid and semi flexible. These systems are custom designed to suit the client's requirements.
Rigid Isolators came into existence due to the need for containment in the Nuclear Industry and eventually found its way to the Pharmacutical industry due to its benefits primarily relating to Safety for the Users, Product & Environment. Use of Containment systems for Asceptic processes and handling API’s have become more prevalent today. Besides safety another aspect due to which conventional cleanrooms are being replaced by containment technologies is due to remarkable affordability thanks to the possibilities of integrating other process equipment within containment in the production stream as well as filtration systems put together which leads to savings in costs for supplying fresh air constantly.
The Bectochem range of containment systems are designed to permit manipulation of highly potent substances. Containment systems are designed for the containment of potent entity during various unit operations involved in R&D, Pilot & Production scale manufacturing processes. Similarly in Asceptic production our focus is not only in high standards of cleanliness – almost germ free environments of liquids, lablets & powders but also qualification of an Isolator for cycle developments with vaporizes Hydrogen peroxide for decontamination.
Besides introducing Bectochem has pioneered the engineering of integration with various process equipments involving dry material and wet mass handling with guaranteed performance. We ensure that the operator protection significantly in the range of OEB 3 to OEB5.
1. Controls in Fully PLC with HMI/ Push button ATEX Rated as option with 21 CFR Part 11 compliance
2. Design criteria - ISO 10648-1/ ISO 10648-2/ ISO 14644-7 & GAMP 5 compliant systems
3. Intermediate doors for access to adjoining chambers.
4. Ergonomically designed life-size models with front and rear operator working positions
5. Transfer Technology– via Pass box with safety interlocks/RTP - Rapid Transfer Port/Split Butterfly Valves/ continuous liner port arrangement.
6. Controlled environment: temperature, humidity and oxygen content - % RH+T provision
7. Manometers for the internal pressure control
8. High level of automation for airflow controls
9. Provision for auto pressure tests.
10. Ergonomic system design
11. Drum tilting & loading arrangement/ Inflatable de-flatable sealing arrangement
12. Integrated WIP
13. Lift-up windows Gull wing type for ease of accessibility & maintenance
14. Safe change with “push-push” filters
15. Support for assessessment for the level of containment required for manipulation of different hazardous products. Performance testing to achieve OEL parameters for containment systems- testing & validation by in house process team.
16. Full cGMP and FDA compliance with FDA 21 CFR Part 11 upon request.
17. Test reports and IQ, OQ, DQ, FAT, SAT documentation.
DISPENSING & SAMPLING
Suitable for both large and small scale operation .They provide operator, environment and product protection, and facilitate both the loading and unloading of products which require containment. They enable bulk and process container product transfer, feature integrated weighing systems, and afford low OEL protection. They are available in a range of versions, giving transfer from differing bulk containers into IBCs, drums,carboys, bags or liners.