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What is stability chamber :
Stability Chambers are specially designedequipment for the testing of products and also to determine their shelf life such as drug, electrical components, industrial materialsetc which enables you to tweak parameters like temperature, humidity to conduct a thorough check over varied conditions.
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Use of the stability chamber :-
It help for the testing of drugs in varied conditions of temperature, humidity, pH, radiations etc. They are also used to check for how long the product will be efficient to use.
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What is the stability Guidelines :
ICH Guidelines , WHO Guidelines, cGMP guideline for shelf life study.
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Objective of Stability Studies
| Objective | Type of study | Use |
| To select adequate formulations and containor closure system | Accelerated | Development of the product |
| To determine shelf-life and storage conditions | Accelerated and real time | Development of the product and of the registration dossier |
| To substantiate the claimed shelf-life | Real Time | Registration dossier |
| To verify that no changes have been introduced in the formulation or manufacturing process that can adversely affect the stability of the product | Accelerated and real time | Quality assurance in general, including quality control |
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Storage Conditions :
| Conditions Name | Storage temperature (C) | Relative humidity (%) |
| Real Time | 25 C +/- 2 C | 60 % +/- 5 % |
| Long Term | 30 C +/- 2 C | 65 % +/- 5 % |
| Long Term | 30 C +/- 2 C | 75 % +/- 5 % |
| Accelerated | 40 C +/- 2 C | 75 % +/- 5 % |
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Why 21 CFR Software compliance require?
The major challenges that the auditor has that all the data submitted of the testing should be authentic and non tempered. This will only possible if it is 21 CFR Complied data is there. Thats why it is important to have stability chamber with 21 cfr complied compliance.
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What is DQ,IQ,OQ,PQ documents?
Normally Manufacture gives the User set of documents or say checklist kind of documents which on completition of doing will check the Stability chamber thoroughly on all the parameters.
| Terminology | Full Form | Use |
| DQ | Design Qualification | This confirm that How de design the chamber and why certain component has been selected. |
| IQ | Installation Qualification | This confirm How to Install the equipment by checking all the component Make, sl No and certificate, Preinstallation requirement and Utilities. |
| OQ | Operational Qualification | This confirm the operation wise checking of all the paramenter of the equipment. |
| PQ | Performance Qualification | This confirm the performance qualification of the stability chamber. |
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What is Validation of the chamber and its protocol?
Validation means checking the performance of the chamber on accuracy and uniformity by placing sensors at different location for specified time interval and checking report for its Confirmatory. Normally Validation will be Onsite ( Checked by the Manufactory on its location ) and offsite at Buyer location. It will be empty, Part load and Full Load depending on the validation protocol.
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Why Hamco?
Hamco has reach experience in designing and manufacturing stability chamber since last 15 years. We are having more than 1000 successful installation in India and globe. We are strong service support with In house manufacturing and software design capabilities.
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Type of stability chamber.
Hamco is making below said Table series stability chamber
| Series | What it Includes | Benefits |
| PID Series | Hamco 44 Series | Chamber Only. No USFDA, WHO , GMP Compliance |
| Normal series | Consist of Chamber (Hamco 44 series) + RS 485 communication Card (PCI-1) + Data Logger (RCR-11 + SOFTD-21 (Desktop browser based Software Part 11 21 CFR )
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WHO Complied |
| ECO Series | Consist of Chamber (Hamco 44 series) + RS 485 Communication card(PCI-1) + HMI PLC ( 4.3 Touch Screen PLC Display ) + DS ( Door Access System ) + SOFTW-21 (Web based Software Part 11 21 CFR ) | WHO, USFDA, GMP Complied |
| Premium Series | Consist of Chamber (Hamco 44 series) + Ethernet Based Connectivity + HMI PLC ( 7 Touch Screen PLC Display ) + DS ( Door Access System ) + SOFTW-21 (Web browser based Software Part 11 21 CFR ) + S.REF-1 ( Standby Refrigeration System) + SH-1 ( Standby Humidification system ) + SCN-44 ( 4 Temp + 4 RH sensor ) + VAL ( Validation)
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WHO, USFDA, GMP Complied.
Redundency for Failure of any component for Long studies. Scanner for Auto validation of the chamber. Mobile and E-mail alert for critical alarm to deliver on mobile or e-mail. |
Stability Chamber Manufacturer in India
The Purpose of Stability Chamber Manufacturer in India is to provide evidence on the how the quality of drug substances or drug product varies with time under the influence 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 Stability Chamber Manufacturer in India serves as an important Quality attribute of the product.
HAMCO Make GMP Stability test chambers are especially built to Pass FDA and ICH Q1A compliance standards and have a reputation for reliability, quality and performance. Exceed FDA/ICH guidelines for long term,intermediate and accelerated Stability studies.
- Temperature Range 5.0 °C to 60.0 °C. Accuracy +/- 0.1 °C. Uniformity +/- 1.0 °C
- Humidity range : 25% to 95% RH, Accuracy +/- 3% RH , Uniformity +/- 3% RH.
- Temperature Display : Digital LED 3 ½ digit, Resolution 0.1 deg C
- Humidity Display : Digital LED 3 ½ digit, Resolution 1% RH.
- Heating system: U shaped Nichrome wire heater in SS Sheathing.
- Cooling system : Hermetically sealed CFC free Emerson compressor with R 134a refrigerant .
- Humidity system : Non condensing type steam injection system with water level arrangement with insulation to save heat energy.
- Air circulation : Flange Motor with Impeller and blower.
- Interior Illumination for working Area.
- There will be two nos of blower from 450 Ltr Onwords.
- Double walled , gap between walls filled with PUF Insulation.
- Standard Model : Stainless steel Mirror polished chamber and heavy guage Powder- coated CRC exterior.
- GMP Model : Stainless steel Mirror polished chamber and exterior of dull finish stainless steel.
- Double door : Inner full Viewing door and outer door insulated with lock and key arrangement.
- 50mm Validation Port with silicon rubber seal to insert sensor for validation purpose.
- 3” Thick CFC Free Puff Insulation.
- Stainless steel Trays. Adjustable Tray Height adjustment.
- Unit Mounted on castor wheels with front lock arrangement.
- Microprocessor based PID temp. controller with auto tune facility for precise control of temperature and humidity.
- Temp. Sensor : PT- 100 , RH sensor : direct capacitance type.
- Dedicated safety controller with separate sensor to cut off the supply in case of overshoot and undershoot of temperature giving audio visual alarm.
- Recorder data bank to store and print set values , process values , date and time of master controllers with variable print time intervals ( Optional)
- Alarm : Audio visual alarm if temperature deviates from the preset temperature.
- PC Interface communication card with RS 485 for temperature and humidity control system ( Hardware only) ( optional)
- Over heat temperature and humidity cut off with alarm.
- Low temperature and humidity alarm.
- Low boiler water level safeguard.
- Electrical overload compressor cutoff.
- Time delay for compressor switch on.
- Electrical short circuit breaker.
- Distilled water or DM Water Line. ( consumption will be 20 ltrs/24 hrs upto 450 ltr Model )
- Room temperature around machine preferably at 25 degree C.
- Stabilised input voltage of 230V Ac, 50 Hz, 20 Amps.
- Water drain line with ½” Nozzle to be provided at floor level.
- 21 CFR Part 11 compliant software with audit trial ( who did what and when is recorded)
- Multilevel Passwords.
- Data storage device has online and offline capabilities.
- Multi chamber data acquisition on single software.
- Tabular and graphical report, alarm deviation report.
- Mean Kinetic temperature report and alarm deviation report.
- Audit trial report.
- Attractive reports and graphs.
- Alarm report.
- Time synchronisation.
Ordering Information:
| MODEL NO. | CAPACITY | DIMENSION IN CMS | SHELVES | WT IN KG | POWER | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Standard | GMP | Cu. Ft | Litres | Chamber | Over All | Unit | Packed in wooden case | VAC Hz | Watts | |
| HAMCO44S -3 | HAMCO44 G-3 | 3 | 90 | 45x45x45 | 60x95x110 | 2 | 110 | 165 | 230,50 | 1500 |
| HAMCO44 S-4 | HAMCO44 G-3 | 4 | 120 | 45x45x60 | 60x95x125 | 2 | 125 | 185 | 230,50 | 2000 |
| HAMCO44 S-8 | HAMCO44 G-8 | 8 | 200 | 60x60x60 | 80x110x125 | 2 | 170 | 240 | 230,50 | 2500 |
| HAMCO44 S-12 | HAMCO44 G-12 | 12 | 324 | 60x60x90 | 80x110x155 | 3 | 200 | 270 | 230,50 | 2500 |
| HAMCO44 S-16 | HAMCO44 G-16 | 16 | 450 | 60x60x125 | 80x130x175 | 4 | 275 | 355 | 230,50 | 4000 |
| HAMCO44 S-21 | HAMCO44 G-21 | 21 | 600 | 60x80x125 | 80x130x195 | 5 | 295 | 375 | 230,50 | 4000 |
| HAMCO44 S-28 | HAMCO44 G-28 | 28 | 800 | 80x80x125 | 100x130x210 | 5 | 325 | 415 | 230,50 | 4500 |
| HAMCO44 S-34 | HAMCO44 G-34 | 34 | 1000 | 80x80x155 | 100x130x220 | 5 | 350 | 450 | 230,50 | 4500 |
| HAMCO44 S-53 | HAMCO44G-53 | 53 | 1500 | 60X160X150 | 110X170X210 | 10 | 375 | 475 | 230,50 | 5000 |
| HAMCO44 S-70 | HAMCO44G-70 | 70 | 2000 | 80X160X150 | 130X176X210 | 10 | 400 | 500 | 230,50 | 5500 |
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