Clean Room Solutions 2013

Transcription

1 Clean Room Solutions 2013 Concept Engineering Ltd, 7 Woodlands Business Park, Woodlands Park Avenue, Maidenhead, Berks, SL6 3UA, UK

2 About Concept Smoke Systems Concept have been producing high quality, professional smoke & aerosol generating systems for almost 50 years. With BS EN ISO 9001 : 2008 scope for the design, manufacture and supply of non-toxic smoke generating equipment and aerosol generating equipment for scientific, military, security and industrial use, we are in an unrivalled position to offer the best advice and the highest quality smoke generators available today. Over the years Concept have developed their Clean Room Solutions range to meet the requirements of the end users. Whether that is for clean rooms, HEPA / ULPA / HVAC systems, LEV tests, air flow visualisation, nuclear lab s, ventilation and exhaust extraction, filter integrity testing (DOP). The range offers: Aerosol generators capable of using Ondina EL (Smoke Oil 135) or Durasyn 164 (Emery Oil 3004) Low to high outputs to suit different size applications Particle size of just µ mmd Stainless Steel as standard Hand held foggers for flow visualisation and clearance testing Smoke wand Concept have designed and manufactured many unique projects, if you would like more information please contact Trevor Dunnington Technical Director +44 (0)

3 VC Aero 1300 / 5000 Particle size μ mmd Meets ISO Fully automatic self-purge after every operation Wide range of outputs to suit systems of all sizes Stainless steel casing Splash proof switching IP 65 Microprocessor with PID Control Machined heater block, guaranteed for life Quick connect coupling to any size of inert gas bottle 2kg Supalite aluminium CO2 cylinder and regulator supplied General Specification (approx) VC Aero1300 VC Aero 5000 Size (cm) 35 x 19 x44 55 x 19 x 44 Weight ((kg) Heat Exchanger (w) 600w or 1100w or 2200w 600w or 1100w or 2200w Power Supply 230vAC, 50-60Hz 230vAC, 50-60Hz Optional 110vAC, 50-60Hz 110vAC, 50-60Hz Warm up time from cold (min) 4 4 Duration at max output before refill (minutes) 112 (600w) 40 (1100w) 22 (2200w) 407 (600w) 145 (1100w) 85 (2200w) Smoke Reservoir capacity (nominal ml) Aerosol output (μg/sec) 0.6kw Aerosol output (μg/sec) 1.1kw Aerosol output (μg/sec) 2.2kw 0-166, , , , , ,000 Smoke Particle diameter (micron, mass median) Remote operation Included with every model Included with every model

4 VC Aero 1300 / 5000 The VC Aero range of systems produce a consistent aerosol particle size and distribution throughout a wide range of pressures and are ideal for challenging HEPA filters to EN-ISO SectC.6.3 in the nuclear, pharmaceutical and clean room industries. The units can be configured to use Ondina EL (Concept SO 135), Ondina 919, or Emery 3004 (Durasyn 164) PAO. The VC Aero incorporates a digital microprocessor controller with dual, 2 colour digital temperature (actual and target) display and PID control, selfdiagnostic testing, switching via a solid state relay for optimum controllability and reliability. The PID controller pulses heat into the unit as the main set point is being reached minimising overshoot and undershoot. The unit is available in 3 heat exchanger sizes so, there is a version of the VC Aero to suit small to large scale applications. Aerosol from the VC Aero s can be passed through flexible ducting if required using optional ducting adaptors (25mm, 50mm and 75mm available) and positive pressure fans if required. All units are supplied with a remote control. The correct functioning of HEPA filters is normally tested at the time of installation, as well as part of the routine maintenance programme. It is normally recommended that HEPA filters are checked at intervals of 6-12 months, or immediately after filter changing. Where high efficiency filters are fitted, it is vital that the filter housing / sealing device does not allow particulate material to pass and thereby compromise the clean room environment that is being supervised. The filter integrity test, which uses a thermally generated aerosol as the detection media, is usually referred to as a DOP test (the original chemical being used for this being Di-Octyl Phthalate). However the industry has adopted specific white mineral oil or PAO as the testing media because of concerns over the safety of the original Di-Octyl Phthalate. The VC Aero is the perfect instrument for challenging HEPA filters and is used world-wide by major blue chip pharmaceutical companies. All units are provided certification of conformity. If required specific particle size calibration can be supplied using the facilities of AEA Harwell at extra cost.

5 MiniColt 4s Air Flow Visualisation Stainless Steel casing Water based, non-toxic smoke Compact and robust Off Power Capability Persistent smoke, remaining visible for long periods (30 minutes +) Controllable smoke, from a small wisp to a large plume Class-leading particle size of just 0.2 micron mmd The MiniColt 4S has been designed for air flow testing, visualization tests and particle recovery work. It is a completely portable unit and has the ability to produce anything from a small wisp of artificial smoke to a large plume, on and off power. Pharmaceutical grade smoke chemical, stored in a one-piece aluminium canister is forced under pressure through the precision machined heat exchanger, where it is vaporised. The vapour condenses to form a smoke effect with a class-leading particle size (an order of magnitude smaller than most conventional smoke systems) which means that dense smoke can be achieved for a substantially lower concentration of chemical in the atmosphere. General Specification (approx) Mini Colt 4 Size (cm) 33 x 15 x 19 Weight ((kg) 5 Heat Exchanger (w) 1100 Power Supply Optional Warm up time from cold (min) 5 Duration of aerosol at max. output (min) 14 Smoke output 1.5m visibility) Smoke Particle diameter (micron, mmd) vAC, Hz* 110vAC, Hz* fully adjustable The high boiling range of the smoke chemical used results in an aerosol or smoke of exceptional persistency, so it remains visible for long periods. (30 minutes +) Operation Off Power Remote operation (*50-60Hz only) Basic and Hybrid versions Hybrid version only

6 MiniColt 4s Air Flow Visualisation The resulting smoke has been analysed by independent laboratories to ensure that it is both non-toxic and nonflammable. Canisters re-seal after use, so no wastage occurs and part-used canisters can be utilised later. The artificial smoke from the MiniColt 4 can be ducted using optional ducting adaptors (to suit 25, 50 and 75mm ducting) enabling the smoke to be introduced into a restricted area, duct or fume cupboard very simply. Testimonial My engineer in my absence as you know tested the output of the Colt into a glass jar and it stayed visible for at least half an hour. He then took the equipment to a real cleanroom. Gave them some instruction on how to operate for the particle recovery testing and they tried it out. My contact told me the test was successful and they not only had good results from the particle recovery but the Colt also provided them with valuable visible information on the behaviour of aerosol in the rooms. So all round very pleasing results. EU GMP / PICs / U.S. FDA / W.H.O. Why use Smoke? WHO GMP FOR STERILE PHARMACEUTICAL PRODUCTS Working document QAS/ Rev.1 Grade A: The uniformity and effectiveness of the unidirectional flow shall be demonstrated by undertaking airflow visualization tests EU GMP Annex 1 Revision: It should be demonstrated that air-flow patterns do not present a contamination risk PHARMACEUTICAL INSPECTION CONVENTION (PIC/S) GMP Annex 1 Revision 2008 Interpretation Of Most Important Changes For The Manufacture Of Sterile Medicinal Products - Recommendation January 2010: Non-viable particles should be measured and are expected to meet grade A requirements. Smoke studies should be performed. U.S. FDA cgmp2004 : it is crucial that airflow patterns be evaluated for turbulence or eddy currents that can act as a channel or reservoir for air contaminants. In situ air pattern analysis should be conducted at the critical area to demonstrate unidirectional airflow.

7 Concept Aerotech Smoke Wand Stainless Steel casing Cleary Defined Plume Variable Controls Simple to Operate Rapid Start Up Low Oil Consumption Oil Level Indicator Hand Held Prope Extension Handles Replaceable Vaporisers Concept s Aerotech Smoke Wand is designed to facilitate the observation of air movements in many types of flow situations. Ideally suited for use where a precise point source of smoke is required, it is easily transported to the site of investigation, is rapid and convenient to set up, and is easy to use. The smoke is produced by peristaltically pumping an innocuous, medicinal quality white oil from the control unit to the tip of the probe, where a low voltage electrical coil heats it to produce a dense plume of smoke at exactly the point where it is needed. The probe is shaped to minimise wake generation that would otherwise invalidate observations, so the emission of the smoke into the air stream is smooth and steady, and is easily controlled to suit prevailing conditions. A stable and clearly defined plume of smoke up to 5m in length can be generated in an aerodynamically clean duct in wind speeds up to 90m/sec. In any situation where air movements need to be observed the Concept Aerotech smoke wand provides the answer, conveniently and economically. General Specification (approx) Smoke Oil Capacity Vaporiser Power Dissipation Smoke Oil Consumption Smoke Wand 400ml 90w max (30v : 3Aac) Average 60ml/hr Power Supply v 50hz, v 60hz Concept Aerotech Smoke Wand over a tennis ball in a small wind tunnel.

8 Concept Air Trace S Specification: Output: 100 cubic feet/minute Power Consumption: 75 W Tank Capacity: 110 cc Battery (supplied): 12V DC/2.3Ah Consumption: 2 cc/min Weight: 2.7 kg Dimensions: 227 x 66 x 81mm The Concept Air Trace S is perfect for situations where a small amount of smoke is required for air tracing applications or in remote locations where no power is available. It is capable of producing a steady stream of smoke, if required, for up to 10 minutes on a full battery or up to 1 hour, with the optional mains adaptor and dummy battery. An extension pipe 200mm x 15mm bore is included to allow precise placement of the smoke. It is used heavily in the clean room, pharmaceutical and nuclear industries as mean of detecting localised air flows. The unit is very simple to operate, and makes smoke on demand, with no warm up time. Every Air Trace S is a complete ready to use kit, including: Air Trace S smoke generator Battery 12vDC Recharger and Lead Optional Extras: Mains Adaption Kit, Radio Remote (315/430Mhz), Spare battery Extension spout for precise placement Professional Carry Case 500ml Smoke Fluid (250 minutes worth)

9 Concept Smoke Systems ISO Certification

10 For more information on Concept Smoke Systems please phone / on: +44 (0) info@conceptsmoke.com Or visit: