air handling unit gmp

CALL +44 (0)1706 228416 Published Features and Articles Spare Parts and Consumables For all servicing requirements please telephone +44 (0) 1706 242202 Envair service engineers are factory trained on a comprehensive range of clean air and containment equipment and are fully conversant with all relevant standards and guidelines. Clean air and containment equipment must be tested and serviced on a regular basis to ensure safety, performance and, of course, compliance with standards, regulations and good manufacturing practice. As manufacturers with a very wide user base, Envair is well placed to ensure that its service engineers are fully up-to-date with developments in design and technology. This enables them not just to test and service Envair equipment but to test, service and optimise the performance and function of all clean air and containment installations. KI Discus (Operator Protection) Isolators (glove boxes) - all types Class I, II and III microbiological safety cabinets

Horizontal and vertical unidirectional (laminar) airflow cabinets and enclosures Powder handling products including downflow booths Ultra clean air operating theatres Cleanrooms and containment suites ISO 14644 series: Clean rooms and associated controlled environments EU GMP Annex 1:2008 Pharmaceutical Isolators, Pharmaceutical Press, 2004 EN 12469: Biotechnology - Performance criteria for microbiological safety cabinets IEC 61010-1:2001 (BS EN 61010-1:2001) Safety requirements for electrical equipment for measurement, control and laboratory use. - Part 1: General requirements The management, design and operation of microbiological containment laboratories, ACDP/HSC, 2001 HTM 03-01 Specialised ventilation for healthcare premises The Service office staff are responsible for co-ordinating all service activities including commissioning, service contracts, call-outs and spares. The office is fully computerised and the engineers' programmes are organised from the office.

For new installations and new customers, detailed quotations are produced. For existing service customers, renewal quotes are sent out before existing contracts expire. The aim of the co-ordinators is to provide a friendly and efficient response to all service customers. Site design by Fourwest Media Copyright © 2015 Envair Limited.Stability Testing Chambers - Walk-Ins Darwin Chambers Company provides turn-key, walk-in stability test chambers for applications requiring adherence to FDA, ICH, and GMP guidelines. Our standard designs offer the most accurate, uniform, efficient, and cost-effective solutions available today. With a long and growing list of the smallest to the largest companies and institutions involved in stability testing, we understand what it takes to give our customers the best available products and the most stable results. Click here to view our basic room pricing special! The design of our walk-in stability chambers are based upon four simple goals:

Quality – All of our products are designed, manufactured, and installed by factory personnel or factory-trained personnel, with an acute understanding of the needs of the pharmaceutical industry.
fan-coil units van rhossQuality is reflected during all phases of a project, from initial quotation, through installation, and after years of operation.
7.5 ton ac compressorIn our opinion, when considering all potential costs for both our customers and our company, quality is clearly not an option, but rather a standard.
hvac nashville tn reviews Speed – We stock nearly all components necessary to build standard, or reasonably custom, chambers in a very short period of time. All major components to each room are tested prior to shipment. Our temperature control systems are pre-charged, tested, and wired for exceptionally fast on-site installation.

We consolidate shipments, where possible, to save on shipping costs, reduce shipping problems, and smooth overall installation logistics. Where competitors often call out 6 month lead-times we may call out 6 weeks or less. Performance – Utilizing an effective blend of the most trusted and recent technologies available has allowed us to design and produce what we consider to be the highest performing walk-in stability testing chamber. We excel in the actual calculated electrical efficiency of each room using high efficiency EC (Electrically Commutated) fan motors, high performance 4” polyurethane foamed-in-place panels, UV-disinfected ultrasonic humidification, and our unique PFTCU (Precision Fluid Temperature Control Unit). On-site validation services that have included multi-point temperature and humidity mapping have repeatedly proven nearly unbelievable uniformity and control results that far surpass FDA/ICH/GMP guidelines. Price – All of the most exciting technologies in the world do not mean anything if the price is not within budget.

Our chambers exceed performance specifications while lowering cost projections. We, like many other manufacturers, feel price increases on everything from materials, to fuel, to health care and yet have still succeeded in maintaining truly reasonable pricing. We are tirelessly engineering better solutions that improve our product performance, reliability, and price. We believe there are many considerations to include in our price view, including: initial installation costs, electrical efficiency, lost “down” chamber time, service costs, and testing results. Darwin Chambers Walk-In Stability Chamber Benefits Cooling/Heating system is fully pre-charged and tested This allows our technicians to set each system in place quickly and reliably. Because there are no refrigeration lines to braze, there are no fire risks, no “burn permits” needed, and fewer opportunities for errors in the field. Each conditioning system can be replaced very quickly in the future due to simple water-type connections.

This ease of installation/removal also allows for greatly simplified future relocation. A typical 9’W x 10’D x 8’ 4”H walk-In stability room will require fewer than 1000 Watts to operate at 25°C/60% and 30°C/65%. At 40°C/75% the efficiency (typically 500 Watts or less) is even better. This savings can be substantial in comparison to competitors (up to $2000 per year) especially when multiplied by the operation of several rooms. Reliable & Low Down Time A glycol/water hydronic heat exchanger in each of our stability rooms operates at very low pressure (0 to 10psi) and the fluid escapes far slower from small leaks than pressurized refrigerant gas. If a leak ever develops in the hydronic coil, the system can be immediately brought back on-line with the addition of more fluid by any available technician with no down-time on the chamber. Permanent repair of the hydronic coil can take place very easily at nearly any point in the future. In contrast, typical refrigeration evaporators operate at high pressures (60 to 120psi) and the refrigerant escapes quickly through even microscopic holes, rendering the system rapidly inoperable.

A trained refrigeration technician must be able to be brought in, find the leak, fix the leak (if possible), assess the condenser for moisture damage, replace the system filter, pull a vacuum on the repaired system, recharge the system to the required specifications, and verify operation. These types of refrigeration repairs are exceptionally costly and incredibly time consuming. Even after refrigeration repairs are conducted, it is often nearly impossible to determine if the system has been compromised. To paraphrase, the differences between the two types of thermal control systems is stunning. Our entire cooling and heating package can be swapped out with a new unit, if ever needed, in minutes rather than the days (or weeks) needed to fix a conventional system. In addition to the time benefits, non-certified technicians can perform the above equipment swap in contrast to conventional systems that require certified refrigeration technicians. Our stability rooms that include an optional redundant refrigeration system allow uninterrupted operation upon a refrigeration failure.

The room does not need to be taken out of service during repair, as the failed system can be isolated and serviced with no impact upon the chamber operation. Darwin Chambers Walk-In Stability Chamber Standard Features Pre-charged and tested conditioning system Foamed-in-place urethane panel construction Refrigerants, foam panels, electrical components, and finishes comply with the appropriate “green”, GWP, LEED, or other environmental standards Full user training and operations support Ultra-efficient EC Fan Motors UV sterilized ultrasonic humidification Isolated, “no down-time” hot gas valve Vapor proof t8 light fixtures Stainless steel front, NEMA 4 control enclosure with key lock Low profile interior air handling unit No “burn permits” required to install Rotronic 0.8% RH (listed accuracy) sensor 100 Ohm Platinum RTD Remote alarm dry contacts RS 485 serial communication outputs Temperature control ±0.1°C at sensor