stability chamber

Galaxy Series The Star Galaxy stability chamber ™ HALT/HASS systems are integrated test chamber/vibration table packages. These chambers are outfitted with a liquid nitrogen (LN2) cooling systems in order to provide the rapid thermal change rates required to achieve maximum product stress. The vibration table is a six degree-of-freedom (6DoF) tri-axial pneumatic vibration table. Two bi-parting doors (one front, one rear) Pneumatically actuated door latches with thermal limit door interlocks Four windows - two front, two rear One rectangular access port with plug and phenolic cover LN2 cooling with proportionately actuating control valve LN2 inlet vacuum jacketed Full LN2 piping assembly vacuum jacked Interior lights ETL (UL STD 508A) approved main power panel Chamber-mounted PC with StarView control software StarView software and control package with 4 input spectrum analyzer for vibration data, including one accelerometer for control of the vibration

Stability chambers are designed to control environmental parameters such as temperature, humidity and radiation levels. Naturally it is essential to demonstrate that a chamber can in fact control these parameters within a specified accuracy, at all points in and around the chamber, over a time period specified. Stability chamber can vary in size, and often they are used to store critical pharmaceutical product. After the initial validation exercise many companies proceed to monitor these chambers with alarms on the critical parameters. Strictly these chambers should operate with levels of assurance similar to those achieved in the validation of autoclaves. So a periodic re-validation exercise is necessary. Stability chamber temperature ranges can vary from 40°C to -80°C. TQSoft™ can perform validation studies with industry standard recorders such as those from Yokogawa. Recorders are often the best choice because they can be setup easily with TQSoft™ to calibrate and map temperatu

Temperature and Climate in Perfection The VT stability chamber with temperature and climate test cabinets VT³/VC³ with patented climate and temperature conditioning system set standards with regard to ease of operation, performance and equipment. The particularly robust test cabinets create more productive, comfortable and clear tests for a great number of products. Features Comfortable operation with an 8" TFT touch display. A lighted Control pad displays the operating mode. Optimal network: Using interface and web server the authorized user can reach current tests via internet. Measurement Data, reports, etc. can be managed in the network and the software Simpati can connect and utilize tests. Security, comfort and performance: The VC³ is able to maintain demanding climate values also under considerably strain, e.g., by midsummer-like ambient temperatures. Reduced upkeep and maintenance costs: Humidity bath purging prevents contamination of humidifier

Following studies are carried by Intertek Stability studies for stability chamber are an essential component of pharmaceutical development, allowing evaluation of active pharmaceutical ingredient (API) stability or drug product stability under the influence of a variety of environmental factors such as temperature, humidity and light. Data from these studies enable recommended storage conditions, retest inte rvals and shelf lives to be established. It is important that you select an experienced stability study outsourcing partner who offers efficient study management, flexible storage conditions and testing capabilities which satisfy all regulatory criteria for your real time, accelerated or forced-degradation study requirements. Stability testing can present significant analytical hurdles, with specialised knowledge required to develop and validate stability indicating methods and perform analysis of leachable substances which migrate from pharmaceutical packagin

These chambers are double walled convection heated units, where in the outer body is made of thick PRPC sheet and the inner chamber is made of heavy gauge stainless sheet of SS-304 grade or anodized aluminum. The gap between the inner and outer wall is filled with high grade mineral glass wool, which in a way makes sure that maximum amount of thermal efficiency is attained. They are also incorporated with programmable alarms and a display screen that that allows constant monitoring of the device for any fluctuations in the temperature or other parameters. These enclosures are energy efficient, extremely reliable, have a sturdy construction and include corrosion resistant interior and exteriors. Stability chambers are available in both standardized and customized models that are designed as per the requirements of the industry. A part from stability chambers we are even leading manufacturers of photo stability test room across India and abroad. These chambers use UV a

IQ/OQ/PQ for stability chambers Following steps are performed by Meditech Technologies private India Limited to perform stability chamber qualification. Basic Overall Approach Meditech performs the basics of all qualifications. IQ/OQ and PQ are therefore performed prior to use. To begin the testing, Meditech establishes the operation conditions such as temperature and relative humidity and prepare IQ/OQ/PQ protocols based on the pre established user requirements specifications. The acceptance criteria for the above tests and mappings are clear on the protocols. Installation Qualification The first step is to check the correct positioning of the chamber and then check if the chamber and all components are correctly installed, and also the presence of documentation. Documentation usually includes user’s manual, certificates and SOPs. Utilities can be verified at this phase: electrical feeding, water (pressure, pumps, filters and connections) and exhaust. If the chamb

Meditech Saifin stability chamber monitoring system gives independent real-time graphs and audit trails with  alarming and customized report solutions. Meditech has zero risk of compliance with the requirements of the ICH and FDA for monitoring temperature, relative humidity, and other critical parameters for data logging. The Meditech continuous monitoring system offers: Fast and easy IQ and OQ validation and on-site installation services. Low cost of ownership with easy set-up and network connectivity via internet Scale to thousands of monitored locations around the globe. Industry-leading data loggers and instrumentation Wireless data logging and monitoring options 24/7 remote alarming via SMS, e-mail, pager and many more to reduce the risk of imprecise measurements due to out-of-tolerance conditions Gap-free and protected data records for compliance with GxP Custom reports can be schedule and automatically delivered by email, or generated on demand and exported to spre

 Guide to Stability Chamber Qualification Reach in Chambers Reach in chambers are small and less expensive and are used when the number of samples are relatively small or conditions are likely to be changed. These chambers have shelf’s for storing the samples. Walk-In Chambers Walk in chambers are more expensive and are used a large space is required for sample storage and the chamber conditions are likely to remain constant for an extended time. The general temperature and humidity conditions for stability studies as per ICH are as follows 1. Temperature: 25°C±2°C and Humidity : 60%±5%H for Long term studies 2. Temperature: 30°C±2°C and Humidity : 65%±5%H for Intermediate conditions studies 3. Temperature: 40°C±2°C and Humidity : 75%±5%H for accelerated conditions studies 4. Temperature: 5°C±3°C for refrigerator conditions studies 5. Temperature: -20°C±5°C for samples in freezer studies There should be separate chamber for each type of study to be maintained

Stable Climate Stability Chambers Stability Testing for shelf life, accelerated aging, ICH Q1A Whether your testing is for R&D, clinical trials or ongoing stability, our stability chambers provide a stable, temperature/humidity conditioned environment for worry-free operation with a control system that is easy to use and saves you time. Stable Climate II stability chambers are available in temperature or temperature and humidity models.  meditech stability chambers are ideal for ICH Q1A stability testing, shelf life, package testing, accelerated aging for a variety of applications including; Pharmaceutical Products/Packaging; Medical Products/Packaging; Personal Care Products; Consumer Products and Research. All stability chambers meet the ICH Q1A pharmaceutical stability guidelines for a variety of storage conditions. Long Term: Intermediate: Accelerated: 2-8°C, 25°C/60% RH, 25°C/40% RH, 30°C/35% RH or 30°C/65% RH 30

stability chambers are used to test and store a wide range of products in specific temperature and/or humidity conditions. Some Stability Applications Include: shelf life testing stability testing expiration date testing accelerated aging and more Our stability test chambers are ideal for pharmaceutical, packaging, life science, personal care, medical, biomedical storage, research, and more. stability chambers feature one, two and three door models with three shelves per door. For testing that requires a larger size, we offer a large selection designed to fit your testing requirements.

Features of stability chamber Features   • Temp. Control: Microprocessor-based PID Control with Auto-tune, CE Marked • Temp. Sensor: PT 100 RTD, Class "A" • Humidity Sensor: HUMIREL, Capacitance level, - High reliability and long term stability • Temp. Display: Digital LED, 3½ digit • Heating: U-shaped Nichrome wire heater in SS Sheathing • Cooling: CFC Free compressor utilizing R134A eco friendly refrigerant, with condenser, motor and    relay. Complete Unit – Copeland Make. • Steam Injection: Boiler with reservoir made of thick stainless steel, with heater, water inlet control,    low water level safeguard and insulation • Air

Pre-Installation Mandatory Requirement 1. Continuous supply of Distilled water or DM water with a tap for boiler input of ½” BSP at 3 feet height 2. Room temperature around machine preferably at 25°C with air conditioning or a well-ventilated room with an exhaust fan. The surrounding    temperature should not exceed 30°C 3. Stabilized input voltage of 230V AC, 20 Amps. Use of Servo Controlled Stability Chamber is recommended 4. Water drain line with ½” nozzle to be provided at floor level. Safety Features   • High temperature safety cut-off • Low water level boiler cut-off • Electrical overload cutoff relay for compressor • Time delay for compressor switch ON

Calibration and Validation of Stability Chamber i) Calibration • Temperature sensor probe calibration with traceability to ERTL • Temperature controller calibration with traceability to ERTL ii) Validation • IQ, OQ and PQ documentation and protocols shall be provided with equipment. • Documentation prepared / developed for Meditech Technologies India Pvt Ltd. – Ireland, one of Europe’s leading validation    consultants leading validation consultants • Performance Qualification with Temperature Mapping on site. The Performance Validation Test consists of one cycle at any    one temperature point for an 8-hour period. Data is collected in printed format from up to six different points within the chamber.    Temperature uniformity is considered acceptable if the deviation is less than ±1°C of set temperature.

The purpose of stability chamber testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or product under recommended storage conditions. Hence, Pharmaceutical Stability Chamber serves as an important quality attribute for the product. Meditech is the largest producer of stability chamber in India