Description

Client requirements and expectations of the Isolator systems are immense; therefore our containment units and systems need to be individually designed to your precise specifications and meet the requirements of each and every project application. Our designs and solutions are world-class in every way pivoting around meeting stringent standards and regulations. We provide turbulent and laminar flow/unidirectional systems, protecting both the product and the operator (running at negative pressure), to systems offering product protection from the operator (running at positive pressure), each individually designed to your precise specifications. We lead in regulatory compliance, proactively maintaining and exceeding latest ATEX, cGMP and FDA regulations and conform to CE marking legislations ensuring that our customers are supplied with full information and comprehensive validation documentation. With our unparalleled capability and attention to detail project handovers are streamlined, assisting the expedition of the validation process.

Accessories & Options

Our systems whether potent or aseptic in nature can be further enhanced with a number of accessories. One the most crucial aspect of isolation technology is the transfer of product/waste into and out of the containment/isolator systems. Our new Containment Transfer System (CTS) is an advanced high-performance transfer port system combining ultimate safety, simplicity of operation together with unprecedented cleanability. There is no doubt that this system has been fundamental in our quest and success in achieving the first validated 5ng/m³ isolator installation in Europe. In an industry where ultimate containment of all API and potent compounds is paramount, the containment capability of gloves and half-suits is crucial. A simple, accessible means of checking interface integrity therefore is critical. Constructed of acetyl or 316L stainless steel our custom-built testing systems allow both in situ and offline testing, enabling fast, easy measurement, using air pressure to check the integrity of glove and half-suit containment efficiency.

Applications

We offer a variety of solutions to the familiar problems and issues surrounding high containment, whilst offering the flexibility of using many different types of product containers, within single or multi-chamber devices. Our approach is based on providing a tailor-made solution that is exactly right for each specific application under review. The equipment we propose balances optimum operator and product protection with cost-effectiveness and ease of use. Offering advanced ergonomic designs we ensure that your organisation receives the greatest possible cost benefit. Our experience covers a wide range of applications including: the sub-division or dispensing of products to weight, charging potent compounds to reactors, mills and IBC's. Off-loading from filter dryers or centrifuges is one of our specialities, encompassing various methods within single and multi-chamber systems, offloading to ported bags, multi-lined kegs or IBC's. We have extensive experience of applying the principles of barrier containment to secondary manufacturing processes, ranging from supplying large scale installations for, Powder and Liquid Filling Lines for vials, syringes, etc to the relatively small heel recovery and sample isolators. Most pharmaceutical products manufactured today are of extremely high value so safe and efficient recovery of the product deposits (heels) is of extreme economic importance, coupled with the ability to obtain samples for laboratory analysis in a contained manner. As experts in the integration of process equipment we offer a large range of interface Isolators, both with gloves and halfsuits, for the efficient interfacing with Autoclaves, freeze dryers, filter dryers, coating and milling machines plus many more. We also provide many Isolation systems for sterile rather than toxic applications, requiring an environment free from biological hazards and integration of Gas generators, for effective surface sterilisation of the enclosed isolator area.

Special Desings