FLEXIBLE CONTAINMENT

Transcription

1 FLEXIBLE CONTAINMENT

2 Collaboration Partners Bectochem produces a comprehensive range of pharmaceutical process equipment & turnkey solids dosage and liquid manufacturing systems. Introducing barrier isolator technology to India in 2004, Bectochem is the acknowledged expert in the specialised and technically demanding field of design & manufacture of high specification barrier containment systems. The Industries We Serve Pharmaceutical, API Manufacturing, Solids Formulations, Liquid Formulations, Ointment Formulations, Research & Development, Food & Cosmetics Bectochem s product range is to be found in facilities across 5 continents. We strive to provide continuous improvement in our quality and customer satisfaction, supplying right first time and on time with fast manufacturing lead times. Containment Service Providers Co. Ltd (CS) is an engineering company specializing in the application of flexible containment An international leader in the design and supply of flexible containment and integrated systems for all aspects of the containment of potent materials for the Pharmaceutical, Chemical, Medical and Food industries. Extensive experience of the Pharmaceutical Industry Unrivalled practical knowledge of flexible containment technology and the application of flexible containment to new and existing equipment anywhere in the world. A hands on-can do approach to all problems

3 CONTAINMENT AROUND PROCESS, NOT THE PEOPLE!!

4 Flexible Containment A Step Ahead Segregation of equipment or plant Remote charging stations Easy Decontamination and product change overs Safe storage areas Added Benefits of Flexible Containment Any size achievable Can be designed and fitted around existing plant, equipment and pipe work Segregated room/areas within the suite Pressure cascades and HEPA filtration Fully disposable Faster Replacement of PU structure. Canopy around only critical area - A custom built application Easily installed

5 Customer Delight Wide range of flexible isolators / Glove bags to enable customers to safely handle potent compounds. Custom designed and fit flexible isolators to existing and new process systems. Isolators in Flexible film (upvc, PU, PE, etc.),clear acrylic, Stainless steel (grade 316 & 316L) for Aseptic Processing. Sterility Testing. Controlled Atmosphere, including dry air, N 2, low oxygen, etc. Sterile Containment Isolators. Laboratory isolators. Stretcher Transit isolators. Bespoke isolators. Gassed isolators using H 2 O 2 & Ozone. Multi chamber isolators. Transfer hatches (all versions) Rapid transfer ports. Continuous liner transfer systems.

6 Flexible Isolators Features Dedicated airflow systems specified to meet the process application Materials of construction specified in relation to the process requirements Product transfer systems, Waste transfer systems Pressure gauges, Alarm systems, Service connections / ports, Controlled atmosphere systems Equipment interface arrangements Quickly detachable and easily replaced flexible enclosures Flexible materials offering good visibility

7 Flexible Isolators Equipment interface arrangements Multi chamber isolator systems Active air sampler connections Particle counter connections Drum connection systems Advice on glove specification and type Ergonomic test facilities Features Replacement liner units Quickly detachable and easily replaced flexible enclosures Elliptical ports (sizes specified against requirements) Variable height facility (available on request) Easy access transfer systems

8 Rapid transfer port connections Active air sampler connections Replacement liner units Filter Replacing Glove Bags Flexible Isolators Features

9 Flexible Isolator System Advantages The Flexible Units serve 3-fold purposes : Protect operator from getting exposed to the hazardous product. Protect product from getting contaminated with the outer surroundings. Protect process from outside environment. The cost of setting up a central HVAC unit is drastically reduced The are significantly abridged decontamination costs. Negligible chances of a false positive resulting during testing Can be moved and set up anywhere with marginal utility requirements. Offer a high degree of protection and design flexibility. Affordable prices Faster deliveries. Can be used as ventilated/un-ventilated or inert atmosphere. Easily integrated to ozonizers and VHP sterilizers for maintaining sterile conditions while testing. Reduced Operating electricity and utility costs.

10 Flexible Containment

11 Services We Provide Consultancy to the Chemical and Pharmaceutical Industry on chemical containment. Design and supply generic glove bags for for non-routine maintenance operations and process requirements. for valve removal, filter change and any other operations and areas required for wet/dry product sampling. Design and installation of mobile containment units. Generate structured cleaning / decontamination schedules which are area specific. Consultancy on control access procedures for personal working. Provide consultancy for powder handling (packaging, reactor charging, sampling etc.) Provide plant specific procedures for materials, personnel and equipment movement Provide wet/dry sampling, area access control, gowning, de-gowning, housekeeping & maintenance procedures, training for all engineering solutions.. Training in any/all of the above methods and procedures. Design and installation of rigid & flexible decontamination showers and de-gowning areas. Procedures and Provide solutions and procedures for planned breaks in containment. Planning containment for all processes. Front-end containment design for new facilities

12 THANK YOU