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What is Walk In stability chamber :
Walk in 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 Walk in 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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Working principle of Walk in stability chamber :
The Walk in Stability Chamber consists of motor and blower arrangement for air circulation to achieve uniform temperature & humidity across the working area. It is a well-insulated double walled chamber and can maintain the temperature & humidity as per the set point on the controller within the specified limits.
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What is the Walk in stability Guidelines :
ICH Guidelines , WHO Guidelines, cGMP guideline for shelf life study.
- What is the difference between stability chamber and walk in stability chamber?
- In stability chamber you need to stand in front of the chamber and open the door to load or unload the sample .
- In walk in stability chamber , you open the door , go inside the chamber and walk through the chamber to load, unload or change the sample and during this you can close the door.
- Usually walk in stability chamber is bigger version of the stability chamber.
- Normal stability chamber comes around max size upto 3000 Litres. Hamco Walk in stability chamber starts from 4000 Litres upto 100000 Litres.
- Objective of Walk in 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 |
- 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. |
- Hamco Walk in stability chamber Unique Features.
- CE Certified chamber with IP 22 protection safety.
- Precise control of Temperature and Humidity .
- 7 HMI+PLC with capacitance type of display for better performance and monitoring.
- Door Access System ( DS ) : Authorised door access system to allow only authorized person to open the door and maintain door access report with reason.
- Stand by Refrigeration (S.REF1) : Standby refrigeration system with auto changeover facility.
- Stand by Humidification system ( S.H1) : Stand by boiler with auto changeover.
- Scanner ( SCN 88) : 8 Temp + 8 RH sensor for auto validation of the chamber 24 X 7.
- 21 CFR Software ( SOFTW21) : Web based 21 cfr software with multi PC login across the Network with auto backup , data archive facility and many other facility. 18 type of report generation . Multi level user access with password expiry.
- Mobile alert ( GSM ) : Mobile alert system for alarm transmission by mobile sms on the user defined selected alarms.
- E-mail Alert ( EMAIL ) : E-mail alert system for alarm transmission by E-mail on the user defined selected alarms.
- External Hooter ( EX.HTR) : External Hooter which placed on security or QC room horns the buzzer on alarm generation.
- Mobile App (MA) : Mobile app having authorized access by permission giving to server database access to see the chamber live from anywhere through mobile app.
- Complete with DQ,IQ,OQ,PQ of the equipment as well as software
- Validation cycle as per client protocol.
| CERTIFICATIONS | OUR CHAMBERS ARE CE Certified Chambers . We as company is ISO 9001:2008 Certified Company. |
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FEATURES |
Consist of Chamber (Hamco 64 SERIES) + Ethernet Based Connectivity + HMI PLC ( 7 Touch Screen PLC Display ) + SOFTW-21 (Web browser based Software Part 11 21 CFR )
+SCN-88 ( 8 Temp + 8 RH sensor ) + Stand By Refrigeration System(S.REF1) +Stand By Humidification System (S.H1) + Mobile Alert System (GSM) + Email Alert Facility + E Report Facility +VAL ( Validation)+ Ex-Hooter( External Hooter system) |
| RANGE/ ACCURACY / UNIFORMITY | Temperature Range : 20C to 60C , Temperature Accuracy +/- 0.5C , Temperature Uniformity : +/- 2C .
Humidity Range 40% to 95% RH , Humidity Accuracy +/- 2% RH, , Humidity Uniformity : +/- 5% RH. |
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CONSTRUCTION GMP MODEL |
Double walled PUF insulated, Leak-Proof Modular Panels with CAM & Lock Arrangement For easy Assembly At On- Site. Interior Made of SS 304 & Exterior Made of SS 304. The thickness of Puff Insulation is 80 mm. Walking Area is Covered with Linoleum Carpet To avoid Slippage. |
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RACKS & TRAYS |
Stainless Steel Trays for Sample Loading Can also be provided along with the unit. The Trays are mounted on racks That provide support to the Trays. |
| LIGHTING | Floroscent Light are provided , which automatically On when we open the door. |
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CHAMBER PRINCIPLE |
Air circulation by Circulation Motor & Fan will continuously sucks the air from the chamber and Passes it through Air heater, Evaporator and injected steam and through it back to chamber and same air will be recirculated to achieve desired Temperature and Humidity stability inside chamber. Our design reduces the power consumption by 50% and water consumption by 70%. |
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DOOR |
Double Walled Insulated door is provided with an observation window of 300 mm x 300 mm having 2 vacuum glasses. The door is provided with lock & key to restrict Unauthorized access . For Safety the door can be opened from inside even if it Locked From outside. For Ultra Low Temp the person can go inside with precautionary measures. |
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CONDITIONING UNIT |
Air circulation is through Tangential Blowers , Dry Heater , Humidity System, Evaporation ( Cooling Coil ) , Stand by Cooling & Humidification System ( If Applicable) , Stand by Sensor System ( If Applicable). |
| ICH GUIDELINES | Fully Suitable to carry out Stability Studies For Conditions Such As :
25C / 60% RH 30C / 65% RH 30C / 75% RH 40C / 75% RH Also Suitable for Low Humidity ICH conditions Laid out for drug Products packed in Semi-Permeable Containers Such As :
25C / 40% RH 30C / 35% RH 30C / 65% RH 40C / NMT 25% RH Other Than this cycle Please Mention it before order. |
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APPLICATIONS |
Application includes Shelf Life Testing , Stability Testing , Expiration Date testing , Accelerated Aging and testing for Pharmaceutical , Packing , Life science , Medical Storage & R&D activity.
Testing of Stability Sample Done :- To Provide evidence of how the quality of drug product Varies with time under the influence of a variety of Environmental Factors Such as Temperature , Humidity & Light. To establish the shelf Life and storage condition of the drug Product. To Confirm that drug products are assured For their Quality , Safety and efficiency in Marketed packs throughout the cycles of Warehousing , distribution , storage & use. To Monitor the impact of Product quality due to changes in established Manufacturing Process. In Support of Product registration in different Markets. |
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HEATING ,COOLING & HUMIDITY SYSTEM |
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. |
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DQ,IQ,OQ,PQ |
To Help the customers to meet current regulatory requirements for the equipment , Hamco can provide DQ,IQ,OQ,PQ Protocols. This Protocol ensures that the system is properly installed, Operating as per our recommendations , Adequately documented and controlled according to regulatory requirements.
Calibration certificate & Test certificate of critical components along with Operation , Maintenance Manual, Wiring diagram , chamber diagram, sensor position diagram provided. Operation Training of the instruments along with software installation and software Training is part of our Operation Qualification. |
| VALIDATION & CALIBRATION | Calibration of chamber is provided with Treacability against standard used.
Hamco will give one cycle 24 hours Validation report offsite & 24 hours Validation report onsite one cycle . ( Validation is putting temp & RH sensors at different position in the chamber confirming Uniformity at different places in the chamber. ) |
| TEMPERATURE & HUMIDITY SENSOR | High Quality Temperature & Humidity Combo Sensor with 4-20 mA output with stable reading . Temperature resolution 0.1C and Humidity resolution 0.1%RH. |
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DISPLAY |
HMI Display is 7 Color Touch Screen Display of Delta Make with display shows
set & Process Value of Temp & Humidity Active Alarm List Status of Component. Component running Hour display Password Protected Display Alarm List & its History. Graph Display of Temperature & Humidity. Limited Door Access through Password Protection. Auto changeover of Refrigeration system on failure. Auto changeover of Humidity system on failure. Auto changeover of Sensor on failure. |
| DOOR ACCESS SYSTEM
(DS) |
Limited Door access through Password protection. The person with Authorised password can only open the door with reason . In software we get the door access report which shows who open the door , when & for what reason with time stamp. |
| AUTO SENSOR CHANGEOVER (SAFETY-1) | In the case of Master Temp-RH sensor Fails , it switch over to Standby Temp-RH Sensor. |
| STAND BY COOLING SYSTEM (S.REF 1) | In case of Failure of Comp 1 , it switch over to Comp2 , thus reduces down time |
| STAND BY HUMIDITY SYSTEM (SH-1) | In case of Failure of Boiler 1, it switch over to Boiler 2 , thus reduces the down time |
| TEMPERATURE & HUMIDITY SCANNER
(SCN 88) |
8+8 Temp Rh sensor including one Master Sensor Placed at different Position in the chamber to Study the distribution of conditions in the different locations of the chambers and thus helps in Auto- Validate the chamber and helps in easy detection of Drift in the sensor |
| MOBILE ALERT (GSM) | You will get SMS Alert on critical utility paramenters like Temp High & Low Alarm, Humidity High & Low Alarm, Low water Level, Power Fail etc as alarm transmission device. |
| EMAIL ALERT (EMAIL) | You will get Email Alert on critical utility paramenterslike Temp High& Low Alarm, Humidity High & Low Alarm, Low water Level, Power Fail etc as alarm transmission device. |
| EXTERNAL HOOTER (EX.HTR) | In case of any Alarm External hooter will horn the buzzer and give the pop up indication and this has to be mounted on security room for qc room as per buyer protocol.
The cabling from external hooter to chamber will be at buyer scope. |
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CONTROLLING SYSTEM |
The controlling system is Fully PLC Based , It consist of HMI Display , PLC Digital & Analogue cards, Relays, Contactors, Overload Trip devices, MCB.
Separate Connection for Main & UPS ( UPS will be on Buyer Scope). This helps in recording the chamber conditions even during Power fail and capture the event of Power Fail & Resume during the conditions. The control panel has below features. IP 22 Protection. Data Storage of 10,000 Readings. If we set data interval of 30 Mins , it can save more than one year data. Controls Temp & Humidity using PID Loops. Captures all the events Like Power OFF / Resume , Water Level Low/OK , Door Open/Close , etc. Operates as Safety Controller by cutting of Heating device on Over temperature , Cutting of Refrigeration device of Low Temperature, Cutting off Boiler on High Humidity etc and generates Alarms and transmit the same alarm to Multiple locations. Ethernet Port for PC Connectivity. |
| Temperature Safety :-
When Temperature deviates higher side than their prescribed limits , the Heater will be cut off by switchgears & if still go higher than by Thermostate. It generated alarm and horn the buzzer if it deviates. Once it reach within the range , the heating system reset automatically. When Temperature deviates lower side than their prescribed limits , the Compressor will be cut off by switchgears & if still go lower than by Thermostate. It generated alarm and horn the buzzer if it deviates. Once it |
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SAFETY |
reach within the range , the Refrigeration system reset automatically.
Humidity Safety :- When Humidity deviates higher side than their prescribed limits , the Boiler will be cut off by switchgears. It generated alarm and horn the buzzer if it deviates. Once it reach within the range , the Humidity system reset automatically. Low water level safety , In case of Insufficient water in boiler tank , the Boiler is Cut off and it generates the alarm and horn the buzzer . When it resumes, it starts automatically. Human Safety :- All the component has individual MCB for Overload and trip protection. The system has provided with proper earthing. Sensor Safety :- The system has been provided with Stand by Sensor, So in case Master sensor Fails, it switch over to Safety sensor thus reduces the down time possibility. |
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ALARM GENERATION |
Audio & Visual Alarms are generated for :
Temperature Deviation. Humidity Deviation. Sensor Failure. Component Failure. Mains Failure. Door Open Water Level Low Thermostate High |
| PC COMMUNICATION (ETH-1) | Ethernet Based Connectivity for High speed Data transmission. |
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SOFTWARE WEB 21 |
It is Web Browser Based Software( You can access the software from any PC Connected in LAN to Server PC ). Having Below said Features .
All 21 CFR Part 11 Requirements areMet. Web based multi PC LOG-IN software LIVE SCREEN. GMPCompliant-Tamper Proof DocumentationofMeasured data. Can Connect 50 Chambers at a Time. Authorized Access Only. Auto Backup Facility. Password Expiry & Multi Wrong attempt of Password will block the User. Auto Logout for no activity during Prescribed Time. Unlimited Users , Multiple login levels. Can Created Data Log Report & Alarm for Temp & RH. Scanner & Scanner Alarm Report for Temp & RH. Event Log Report Door Access Report. HMI Audit report Etc. GSM Report Email Report Mobile app if required to access the chamber through mobile application. 17 Types of reports can be generated for single chamber |
| E Report facility can be generated. No need to take physical printout with digital signature with time stamp to generate, review and approve reports. Alarm transmission first through external hooter if not attended than through mobile access and then Email Alert. |
| Model no. | Capacity | Dimension in cms | Tray | Tray | |||
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Standard |
Gmp |
Litres |
Chamber | Overall size in | |||
| Cu. | size in mtr | Qty. | size in | ||||
| Ft | (h xw xd) | mtr (hxwxd) | Mm | ||||
| Hamco63s- 3000 | Hamco63g- 3000 |
100 |
3000 |
1.5×2.0x1.0 |
2.2×2.16×1.5 |
10 |
950×950 |
| Hamco63s- 4000 | Hamco63g- 2700 |
140 |
4000 |
2.0×1.0x2.0 |
2.16×1.16×2.16 |
10 |
740X625 |
| Hamco63s – 5400 | Hamco63g- 5400 |
190 |
5400 |
2.0×1.36×2.0 |
2.16×1.52×2.16 |
24 |
870×300 |
| Hamco63s – 6400 | Hamco63 g- 6400 |
230 |
6400 |
2.4×1.36×2.0 |
2.56×1.52×2.16 |
32 |
870×300 |
| Hamco63s – 8000 | Hamco63 g- 8000 |
280 |
8000 |
2.0×2.0x2.0 |
2.16×2.16×2.16 |
24 |
870×600 |
| Hamco63s – 9600 | Hamco63 g- 9600 |
340 |
9600 |
2.4×2.0x2.0 |
2.56×2.16×2.16 |
32 |
870×600 |
| Hamco63s – 12000 | Hamco63 g- 12000 |
428 |
12000 |
2.4×2.0x2.5 |
2.56×2.16×2.66 |
48 |
725×600 |
| Hamco63s – 15000 | Hamco63 g- 15000 |
530 |
15000 |
2.4×2.5×2.5 |
2.56×2.66×2.66 |
48 |
725×800 |
| Hamco63s – 18000 | Hamco63 g- 18000 |
640 |
18000 |
2.4×2.5×3.0 |
2.56×2.66×3.16 |
48 |
900×800 |
| Hamco63s- 24000 | Hamco63g- 24000 |
850 |
24000 |
2.4×2.5×4.0 |
2.56×2.66×4.16 |
60 |
900×800 |
| Hamco63s – 30000 | Hamco63g- 30000 |
1070 |
30000 |
2.4×2.5×5.0 |
2.56×2.66×5.16 |
80 |
920×800 |
| Hamco63s – 50000 | Hamco63g- 50000 |
1785 |
50000 |
3.0×4.2×4.0 |
3.16×4.36×4.16 |
140 |
870×600 |
| Hamco63s – 80000 | Hamco63g- 80000 |
2857 |
80000 |
3.0×4.8×5.56 |
3.16×4.96×5.72 |
180 |
870×600 |
Note: Best walk in stability chamber manufacturer, Walk in stability chamber.
