(@) ees Pharmalabs SVMS-PHARMALAB STEAM QUALITY TEST KIT ‘AtPharmalab, we always believe to deliver the best products to our valued customers. To achieve this wealways try and get the experts’ opinion / collaboration / tie-up for the world class products. For Steam Quality Test Kit, Pharmalab has made a tie up with a UK based company SVMS limited. SVMSisa company originated from Validation Services for Pharmaceutical Requirements. WHAT, WHY and HOW these three are the basic questions related to Clean Steam Quality. | Concept Of Pure Steam Quality Testing FE Clean steam is defined by a steam whose condensate will meet all the parameters that of WFI. Until HTM 2010 was published there had been no requirement for routine physical steam quality testing within the NHS. While HTM 10 (4) provided details of dryness value and non condensable gas tests, these were to be employed as circumstances demanded. Prior to this, testing had been restricted to the subjective assessment of load dryness and the assessment of superheat as part of routine thermometric testing. In the mid of 1970's the British National Health Services was incurring significant costs as the result of failed porous load/equipment sterilization cycles. Failures were principally due to wet loads, the failure of chemical indicators on packaging and in the Bowie Dick test to properly change colour and air detectors causing cycles to automatically fail. In addition to the evident quality issues, this resulted in loads having to be re-packaged and re- sterilized at considerable expense. Poor quality of pure steam and pure steam distribution pipe line designing, steam trap functioning of sterilizer rasiiite in failure of heat dietrihiition.[Conclusion MMM It has been seen that wet steam, superheated steam or non-condensable gases all have the potential to adversely affect the sterilization of equipment loads in the pharmaceutical industry. The extent of which the process is affected will be dependent on the extent of the problem and the nature of the load. Good practice indicates that we should be aware of the condition of the steam we use for sterilization of equipment or porous loads, to both confirm that the design requirements of our steam raising plant have been satisfied and to assist with troubleshooting. While routine testing at an annual frequency at the point of useis indicated by HTM 2010, the period between tests may be inadequate to detect any transient or seasonal problems that exist. Furthermore, itis implicit in HTM 2010 that daily Bowie Dick tests are conducted and equipmentis fitted with air detectors, both of which may under certain conditions detect non-condensable gases. Now, as a GMP, ISO, HTM 2010, EN 285 has defined the quality of steam used for sterilization purpose. Itis necessary to ensure and validate the quality of steam on regular basis. Steam Quality Testing has been a requirement within the EU for many years by ISO EN 285 andis becoming adopted by many other countries and the Pharmaceutical environment across the world. | Requirement: (Physical Properties) [I Non Condensable gases a 3.5% Dryness Value > 09% ‘Super Heat Value < 256 > The SVMS Steam Quality Test Kit range was developed for use by their own engineers to provide a reliable and efficient method of performing the tests. Prior to this, the equipment needed was bulky and difficult to set upand operate. > The Steam Quality Test apparatus incorporates measurement of Non-Condensable gases, Dryness Value and Superheat. > The cleanliness of steam (Clean Steam) was recommended to be adopted in the UK NHS by Health Technical Memorandum 2031 and in the EU by ISO EN 285. These documents provide limits for chemical impurities. HTM 2031 also provides a limit for the level of Bacterial Endotoxins (Pyrogens). ADVANTAGES OF SVMS-PHARMALAB PORTABLE STEAM QUALITY TEST KITS [Genera| > Robust This kit has a robust flight case incorporating extending handle and wheels. This provides a high degree of protection to the kit when in transit. > Efficient Test time is reduced due to the ease of assembly and use. The use of a SVMS Pharmalab Steam Quality Test kit provides means to guarantee that requirements are met in an efficientand easy manner. > Comprehensive This kit provides all the components required to perform Steam Quality Tests. The intention is that an engineer can arrive on site without the need to carry additional tools or bulky expensive instrumentation > Self-Contained tripod is supplied in order to mount the apparatus for the Non-Condensable Gas Value test and is adjustable ‘6 miitabls level. This ebsvisies the need tn frid 6 kullabla workkiefebe io sunportthe squiorient> Convenient A bracket is supplied so that the thermometer can be conveniently mounted on the side of the Non- Condensable Gas apparatus box. > Temperature Measurement An accurate dual input thermocouple thermometer incorporating an averaging facility is supplied with this kit. During the Steam Dryness Value test, the average steam supply temperature can be recorded in the background while the flask temperature is monitored in the foreground. This eliminates the need to use ‘expensive logging orrecording system. » Calculations can bemade: ‘Automatically by using the calculation forms of the CD or By the use of an electronic calculator and supplied tables. > The use of the SVMS-PHARMALAB Steam Quality Test Kit allows you to provide a guarantee that requirements are met in a quick and easy manner. [Non Condensable Gas Value J) » Easytouse Gas and steam condensate volumes are measured by ‘zero adjustable’ calibrated scales mounted behind the sight glasses. These are a permanent fixture. Aburette and measuring cylinder are not needed. » Pipe Connections All water pipe connections are made by 6 mm OD plastic push-fit fittings. As only a low water flow is required, large, bulky hose pipes are notneeded. » Water Supply Water can be supplied directly from a pressurized supply, butsiphoning from a tank at 200 ml per minute is all that is required (minimum requirements: 1.0 meter head, water temperature below 28.0°C). A water pump is not necessary. » High quality steam inlet valve The temperature of the condensate is maintained above 80.0°C by controlling the inlet steam flow through a high quality inlet needle valve. Other kits only control the condensed outlet steam. Greater control is therefore achieved. Measurement of Non-Condensable Gases > Sensitivity The measurement of the condense temperature is made by a sensitive thermocouple probe fitted to the outlet, ofthe condenser. Better control is therefore achieved » Repeatability Tests can be repeated simply by a return to the 'zero scales position’ by opening the condensate drain and gas bleed valves. The valves are then closed when a new sample is required to be taken. > Setting-up ‘The condensate column is placed above the gas column; therefore there is no need to draw the air out before emeiee tal[Dryness Value Measurement of Dryness Value » Flask holder/measuring container ‘As the flask has to be connected within 0.5m of the sampling point, We have incorporated a flask holder in the kit so that the flask can be mounted in a convenient position. This holder also serves as a measuring container to prime the flask. | Supecheat Value [II . Measurement of Superheat Value » Insulation The superheat expansion tube is permanently fitted with a tough and efficient silicon foam rubber insulating sleeve © Pharmalab ©) Pharmalab NDIA PRIVATE LIMITED TECHNOLOGY YOU CAN TRUST i’, Sanghvi Estate, Govandi Station Road, Govandi (E), Mumbai - 400 088. INDIA 91-22-6622 9900 Fax : 91-22-6622 9800 Email :[email protected] Website : www.pharmalab.com