{"id":8955,"date":"2016-10-21T16:53:12","date_gmt":"2016-10-21T11:23:12","guid":{"rendered":"http:\/\/newmeditech.com\/?p=8955"},"modified":"2020-11-14T11:12:44","modified_gmt":"2020-11-14T05:42:44","slug":"photostability-chamber","status":"publish","type":"post","link":"https:\/\/newmeditech.com\/secure\/featured\/photostability-chamber\/","title":{"rendered":"Photostability Chamber"},"content":{"rendered":"

Photostability Chamber manufactured by Meditech Technology for safe testing of specimens<\/span><\/strong><\/h1>\n

European CE Certified Products Presafe DGM897<\/strong><\/h3>\n

Touch Screen and PLC based controller<\/strong><\/span>
\n Inbuilt USB and Data logger<\/strong><\/span>
\n S<\/strong><\/span>tability testing for Pharmacy, Cosmetics, Tablets, Beverages and Food <\/strong><\/span><\/span>
\n 21 CFR Part 11 Ready Software<\/strong><\/span><\/p>\n

Web Based Software (SAIFIN53) – Remote Management<\/b><\/span><\/span><\/strong><\/span>
\n25 years of knowledge, expertise and experienc<\/span>e<\/span><\/strong><\/span>
\n ICH Guideline Q1AR2<\/span><\/strong><\/span><\/p>\n

At 25\u00b0C : RH = 60%
\nAt 30\u00b0C : RH = 65%
\nAt 40\u00b0C : RH = 75%
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Software<\/h4>\r\n\t\t\t\t
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Features of 21 CFR part 11 Photostability Chamber<\/strong> <\/span><\/h2>\n


\n(a) 21 CFR part 11 USFDA compliant software with validation documents. <\/span><\/span><\/p>\n

(b) Multi level security password with aging and history.<\/span>
\n<\/span><\/span><\/p>\n

(c) Electronic signature.<\/span><\/p>\n

(d) Secured audit Trail.<\/span><\/p>\n

(e) GSM alarm system for mobile alert.<\/span><\/p>\n

(f) Web based Ethernet and WIFI online remote monitoring. <\/span><\/p>\n

(g)Data of door access security system in software with remote options.<\/span><\/p>\n

(h)All the events, utility, working status, all the alarms are logged in the software.<\/span><\/p>\n

(i)Reports of mean Kinetic Temperature Reading.<\/span><\/p>\n

(j)Records in graphical and in tabular form.<\/span><\/p>\n

(k)Complete with extensive DQ, IQ, OQ and PQ protocols as per the International guidelines along with calibration certificates.<\/span>
\n<\/span><\/p>\n

(l)Works on 230V AC single phase 50Hz (country specific).<\/span><\/p>\n

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Remote<\/h4>\r\n\t\t\t\t
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Remote Photostability Chamber and Photostability Room Management – Web Based Software (SAIFIN53)\u00a0 <\/strong><\/span><\/span><\/h3>\n

Access Anywhere Anytime!! Around the Globe<\/strong><\/span><\/p>\n

Instantly connect and control your Photostability Chambers and Rooms without installing software. <\/span><\/strong>Meditech SAIFIN53 software has gained popularity among operators for its reliability and ease. SAIFIN53 is available remotely via a web browser using internet facility. SAIFIN53 is designed to meet the increasing demands for improved efficiency. This web based software also adds extra capabilities of data logging, user-configuration and features of all alarm notifications via Email and SMS.<\/strong><\/span><\/p>\n

Features<\/span><\/span><\/strong><\/span><\/h2>\n

(a)<\/span> Eliminate the need for multiple software Qualifications and installations.<\/span><\/span><\/p>\n

(b) Web based software accessible through browser.<\/span><\/p>\n

(c)<\/span>Compatible with server based Operating system, Windows7\/8\/9\/10 and Android .<\/span><\/span><\/p>\n

(d)<\/span>Ensure one-time software installation on your plants server and access the software anytime, anywhere through a web browser from any Desktop or Laptop (same LAN Network)<\/span>.<\/span><\/p>\n

(e)View Status, take printouts or execute any of your tasks from anywhere.<\/span><\/p>\n

(f)<\/span>Department wise segregation of users, equipment & Data.<\/span><\/span><\/p>\n

(g) Harmonization of reporting format (header,footer,etc) and other such operations through the plant.<\/span><\/p>\n

(h)Centralized user defined Alarms,alerts and Notifications through SMS & emails. <\/span><\/p>\n

(i)<\/span>Configure the type & number of alarms to be sent via email and SMS & configure delay time.<\/span><\/span><\/p>\n

(j)<\/span>Running time calculation of MKT and Moving Average<\/span>.<\/span><\/p>\n

(k)Component running hours to determine the shelf-life of major components.<\/span><\/p>\n

(l)<\/span>Real-time display of all connected equipment in single screen.<\/span><\/span><\/p>\n

(m)Automatic data backup facility.<\/span><\/p>\n

(n)<\/span>System Diagnosis for troubleshooting via Team Viewer. <\/span><\/span><\/p>\n

(o)<\/span>Ethernet communication with chambers.<\/span><\/span><\/p>\n

(p)<\/span>Complying US FDA 21 CFR Part11<\/span><\/span><\/p>\n

Key Features of Photostability Software
\n<\/strong><\/span><\/span><\/h4>\n

(1) A Truly innovative data handling and communication options.<\/span><\/p>\n

(2)<\/span>Plug and Play fashion via Ethernet to connect local or plant networked PC or Laptop.<\/span><\/span><\/p>\n

(3)<\/span>One can view LIVE system parameters and historical graphs as well as receive alarms, reports, data log files over email.<\/span><\/span><\/p>\n

(4)Settings with just a standard browser.<\/span><\/p>\n

(5)<\/span>Access live or stored data remotely within the facility (LAN network) of from anywhere in the<\/span> world<\/span>. <\/span>\t\t<\/div>\r\n\t<\/div>\r\n<\/div>
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Test<\/h4>\r\n\t\t\t\t
\r\n\t\t\tPhotostability Tests plays an important step in the development of new drugs and pharmaceutical substances. This is an indispensable element in the licensing process defined by federal regulating authorities. However, these tests are just as important for safeguarding the quality of the product within the framework of quality assurance.<\/span><\/span>
\nTogether with the help of experts in the pharmacy industry and committees from the pharmaceutical industry and experts from the licensing authorities (such as the FDA) have developed the ICH Guidelines for the harmonization of photostability tests. These guidelines define standardized storage and batch evaluation as well as the time sequence of the required analytic tests<\/span>.<\/span><\/span> \t\t<\/div>\r\n\t<\/div>\r\n<\/div>
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ICH Q1AR2<\/h4>\r\n\t\t\t\t
\r\n\t\t\tAccording to the ICH Guideline Q1AR2, photostability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances.<\/span><\/p>\n

Fluorescent tube for day light effect and\u00a0 UV tubes for Ultra Violet ray in accordance to the ICH guidelines requirement of a lightning energy mounting to 1.2 mil lux per hours and integrated UV energy share of 200 Watt Hours per meter square.<\/span>
\n<\/span><\/p>\n

As per ICH guidelines<\/span> :<\/span><\/h6>\n

\u00a0\u00a0\u00a0 At 25\u00b0C : RH = 60%<\/span>
\n\u00a0\u00a0\u00a0 At 30\u00b0C : RH = 65%<\/span>
\n\u00a0\u00a0\u00a0 At 40\u00b0C : RH = 75%<\/span><\/p>\n

MEDITECH offers a range of photostability test chambers to meet these regulatory requirements as well as stability testing requirements for other industry segments of Pharmacy, Drugs, tablets, Cosmetic, Food, Beverages, etc.<\/span><\/span>
\nWe offer a centralized solution across all ICH conditions of real-time, intermediate, accelerated & semi-permeable study conditions along with a state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT and many other such features. <\/span>\t\t<\/div>\r\n\t<\/div>\r\n<\/div>

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Construction<\/h4>\r\n\t\t\t\t
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(1) Photostability Chamber is manufactured on fully automatic CNC machines thereby giving consistency in performance and aesthetic look.<\/span><\/span><\/p>\n

(2) <\/span>CFC Free PUF insulation on automatic machine for better accuracy of Temperature and Humidity.<\/span><\/span><\/p>\n

(3) Photostability Chambers are provided with effective air circulation system, refrigeration system, and humidity system<\/span>. <\/span><\/span><\/p>\n

(4) Full view observation of glass door, chamber illumination and stainless steel perforated trays<\/span><\/span><\/p>\n

(5)Accuracy, Uniformity, Reliability and Economy. <\/span><\/p>\n

(6)The stability chamber is manufactured as per the cGMP Regulations and designed for low electrical and water consumption.<\/span> <\/span><\/p>\n

(7)Stand by refrigeration system and stand by humidity system is provided on reque<\/span>st.<\/span><\/span>\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/p>\n

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Safety<\/h4>\r\n\t\t\t\t
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\n(1) Photostability Chamber is provided with safety cut offs and alarms at centrally located places.<\/span><\/span><\/p>\n

(2) Dedicated Safety system to shut off the humidity system and chamber shut down in case of overshoot or undershoot of temperature or humidity with audio visual alarm.<\/span><\/p>\n

(3) Thermostatic safety system is provided as an additional safety feature.<\/span><\/p>\n

(4)Low water level cut off for humidity system.<\/span><\/p>\n

(5)Door open alarm.<\/span> <\/span><\/p>\n

(6) All the alarms and events are logged in the software.<\/span>
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Monitoring<\/h4>\r\n\t\t\t\t
\r\n\t\t\t \"monitoring-and-alarm\"\t\t<\/div>\r\n\t<\/div>\r\n<\/div>\n
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Control<\/h4>\r\n\t\t\t\t
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Features of Photostability Chamber Controller<\/span><\/strong><\/span><\/h2>\n

(1) Microprocessor-based 7 inch Touch Screen PID controller. <\/span><\/p>\n

(2) Auto tuning for accurate control of temperature and humidity conditions.<\/span><\/p>\n

(3) Printer interface facility to store data and to print it directly on a printer. <\/span><\/span><\/p>\n

(4) Direct % RH electronic capacitor type humidity sensor.<\/span><\/p>\n

(5)Online connection of Touch screen to Computer via Ethernet using TCP IP Protocol for online mapping purpose and data logging. <\/span><\/span><\/p>\n

(6)A PLC system for an auto changeover of standby systems and other event logging and monitoring<\/span> purpose. <\/span><\/span><\/p>\n

(7) GSM mobile alert module to give malfunction SMS on mobiles simultaneously<\/span><\/p>\n

(8)Door Access Security System with smart cards and bio-metrics.<\/span><\/p>\n

(9)Network connectivity via Ethernet for web based online remote monitoring. <\/span><\/p>\n

(10) Utility management system provided for continuous machines operations and cross checks.<\/span>
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Humidifier <\/h4>\r\n\t\t\t\t
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\nMeditech patented ultrasonic humidifier MHumid\u00ae maintains accurate humidity inside the chamber. Within few seconds the humidity is maintained inside the chamber unlike conventional steam heating system. 95% more efficient than steam heating . Thus saving 95% of electricity<\/span>
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Specification<\/h4>\r\n\t\t\t\t
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Model
\n<\/th>		Litres<\/th>Inner Dimension
\nWxDxH cm<\/th>		Outer Dimension
\nWxDxH cm<\/th>		No of Trays<\/th>\n<\/tr>\n<\/thead>\n
MTBBR1<\/td>120<\/td>45x45x60<\/td>65x114x130<\/td>2<\/td>\n<\/tr>\n
MTBBR2<\/td>200<\/td>60x60x60<\/td>76x121x130<\/td>2<\/td>\n<\/tr>\n
MTBBR3<\/td>324<\/td>60x60x90<\/td>76x121x165<\/td>3<\/td>\n<\/tr>\n
MTBBR4<\/td>450<\/td>60x60x125<\/td>76x121x199<\/td>4<\/td>\n<\/tr>\n
MTBBR5<\/td>600<\/td>60x80x125<\/td>76x141x199<\/td>5<\/td>\n<\/tr>\n
MTBBR6<\/td>800<\/td>80x80x125<\/td>96x141x199<\/td>5<\/td>\n<\/tr>\n
MTBBR7<\/td>1000<\/td>80x80x155<\/td>96x141x225<\/td>5<\/td>\n<\/tr>\n
MTBBR8<\/td>2000<\/td>160x75x170<\/td>192x126x189
\n<\/td>		8<\/td>\n<\/tr>\n
MTBBR9<\/td>3000<\/td>190x80x200<\/td>224x131x219
\n<\/td>		12<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div>\n
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Technical<\/h4>\r\n\t\t\t\t
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Technical Data Of Proposed Photostability Chamber<\/span><\/h3>\n

(1) Standard Model(S): Inside S.S.304 & Outside Galvannealed Powder Coated mild steel.<\/span><\/span><\/p>\n

(2) GMP Model(G): Inside S.S. 316 with mirror polish & outside with SS 304 matt buff.<\/span><\/span><\/p>\n

(3) Temp. Range \/Accuracy: 20\u00b0C to 60\u00b0C \/\u00b1 0.2\u00b0C<\/span><\/span><\/p>\n

(4) Temp Uniformity : \u00b1 1\u00b0C<\/span><\/span><\/p>\n

(5) Humidity Range and Accuracy : 40% to 95 % RH and \u00b1 2% RH<\/span><\/span><\/p>\n

(6) Humidity Uniformity : \u00b1 3% RH<\/span>
\n<\/span>\t\t<\/div>\r\n\t<\/div>\r\n<\/div>\n

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Catalog<\/h4>\r\n\t\t\t\t
\r\n\t\t\t Download Photostability Chamber Catalog<\/span><\/a> \t\t<\/div>\r\n\t<\/div>\r\n<\/div>
\n<\/span>
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About Meditech Photostability Chamber <\/h4>\r\n\t\t\t\t
\r\n\t\t\t Meditech technologies India Pvt Ltd manufactures the most innovative photostability chamber series in humidity and temperature applications. These lines of chambers has both thermostatic (temperature only) versions and climatic (temperature humidity) versions.<\/strong><\/span>
\n Meditech has more than 25 years of knowledge , experience and expertise in the field along with feed backs from both customers and distributors. Meditech is highly successful in producing rich features and highly reliable chambers to fulfill customers testing needs.<\/strong><\/span>
\n With Meditech series, one has the ability to apply the laws of nature (temperature and humidity) and allow unknown (possible product defects) to reveal themselves. There shall be increase in reliability and robustness with every test performed on Meditech test Chambers<\/strong><\/span>
\n \t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Photostability Chamber manufactured by Meditech Technology for safe testing of specimens European CE Certified Products Presafe DGM897 Touch Screen and PLC based controller Inbuilt USB and Data logger Stability testing for Pharmacy, Cosmetics, Tablets, Beverages and Food 21 CFR Part 11 Ready Software Web Based Software (SAIFIN53) – Remote Management 25 years of knowledge, expertise […]<\/p>\n","protected":false},"author":1,"featured_media":8957,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"aioseo_notices":[],"yoast_head":"\nPhotostability Chamber - New Meditech<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/newmeditech.com\/secure\/featured\/photostability-chamber\/\" \/>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Photostability Chamber - New Meditech","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/newmeditech.com\/secure\/featured\/photostability-chamber\/"},"_links":{"self":[{"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/posts\/8955"}],"collection":[{"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/comments?post=8955"}],"version-history":[{"count":11,"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/posts\/8955\/revisions"}],"predecessor-version":[{"id":10815,"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/posts\/8955\/revisions\/10815"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/media\/8957"}],"wp:attachment":[{"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/media?parent=8955"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/categories?post=8955"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/newmeditech.com\/secure\/wp-json\/wp\/v2\/tags?post=8955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}