Ertl Model
Get more information about the Stability Chamber
The theory encompassing a concept or idea aids in comprehending the objective, design and purpose of an equipment. Drug stability refers to the capacity of a drug substance or product to remain within established specifications of identity, strength, quality and purity in a specified period of time and is expressed as its expiry period or technically as shelf life.
Osworld Stability Chamber/Climatic Chamber complies with WHO guidelines:
WHO Stability testing indicates-‘Care must be taken to ensure that active pharmaceutical compounds remain stable and unaffected by packaging materials or storage conditions’.
The purpose of stability 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, it serves as an important quality attribute for the product.
Stability studies are a critical part of the drug development process and are essential for drug product marketing approval.The stability of a drug is extremely crucial in drug testing as the physical or chemical instability of the drug acts as a key in determining the storage or shelf life and assuring the overall quality of the product. Stability testing problems are cited in warning letters and sometimes result in costly product recalls.
The stability chamber/climatic chamber sometimes referred as humidity oven/environmental test chamber should be rightly decided on to get accurate and consistent results of the samples under study.
Planning to buy a stability chamber/climatic chamber can be a laborious process considering the competitive brands in the market, filtering from an array of advertisements with bogus proposals and of course deciding on a viable price range. When you plan to buy a stability chamber/climatic chamber it is essential to clearly earmark and plan your study in concurrence with your research of the various equipment designs and dealers.
Here at Osworld, we empathize with the customer and identify their needs to design a customized product. The chamber conditions have a direct effect on product quality. Hence the preventive maintenance and repair are an inseparable part of the equipment purchase. Hence, Osworld assures to be with the customer through planning and designing to purchasing, maintaining the equipment and result. This is the sole reason Osworld has successfully sold over 2000 stability chambers/climatic chambers till date.
Osworld Stability Chamber/Climatic Chamber/Humidity Oven/Environmental Test Chamber:
Stability chamber/Climatic chamber is just one among our “customer acclaimed” products. The CE marked Osworld Stability Chamber/Climatic Chamber/Humidity Oven/Environmental Test Chamber meets temperature and humidity conditions as per ICH guidelines and FDA regulations. With a temperature range of 10.0 ºC to 60.0 ºC and humidity range of 25% RH to 95% RH as per ICH guidelines, these chambers are available in seven size capacities of 4 cu.ft., 8 cu.ft., 12 cu.ft., 16 cu.ft.,
21 cu.ft., 28 cu.ft., 34 cu.ft. according to customer requirements. The controller is a CE marked microprocessor based PID control with Auto tune. The Osworld Stability Chamber/Climatic Chamber is a double walled construction with PUF insulation. Heavy duty SS wire rod trays allows passage of air and helps maintain a high level of uniformity. An inner glass viewing door and an outer key-lockable door facilitates customer monitored entry into the stability chamber/climatic chamber to prevent unauthorized access. All electrical components are either CE certified or ISI marked. It is provided with a Calibration Certificate accredited to ERTL and traceable to National Physics Laboratory (NPL).
Osworld Stability Chambers/Climatic Chambers are basically designed for testing of production samples where control of temperature and relative humidity are desired. Both GMP and Standard models of Osworld Stability Chambers/Climatic Chambers are available.
Osworld supplies ICH/FDA Compliant – 21 CFR Data Storage Software:
Complying to the guidelines of ICH/FDA, Osworld proudly presents 21 CFR Part 11 Software developed for Osworld by Godrej & Boyce Mfg. Co.Ltd, one of India’s most reputed and trusted brands. This compliant software “Oscan” is a data storage software with a data storage device “Oslog” (patent applied/pending) capable of working in both online and offline modes and is recommended as a “must-have” accessory with the Osworld Stability Chamber/Climatic Chamber.
Osworld Stability Chamber/Climatic Chamber comes with ICH/FDA Compliant Validation:
The ICH/FDA compliant validation document furnished with the Osworld Stability Chamber/Climatic Chamber/Humidity Oven/Environmental Test Chamber is an inseparable part of the equipment. All stages of qualification (DQ/IQ/OQ/PQ) are provided. IQ/OQ ensures correct data evolving from samples kept under testing and PQ is imperative in the working of the equipment as intended. Our validation documents ensure training and handling by trained personnel only to ensure safe and efficient handling of the equipment and thus achieve a consistent bank of results from samples under study.
Osworld Repair Service helps keep your valuable equipment up and running with scheduled preventive maintenance and repair. Our experienced service technicians are factory trained and shall be available to attend to all your service needs. Get the best performance out of your equipment by keeping it properly maintained and repaired. Osworld is also a supplier of service assurance preventive maintenance kits for stability chamber/climatic chamber.
About the Author
At Osworld India, you can get information about stability chamber, Walk in Stability Chamber, Humidity Control Chamber& Environmental Test Chamber etc.
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