Walk in Incubator Standard / GMP Model
The Purpose of Walk in incubator testing 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 serves as an important Quality attribute of the product.
HAMCO Make GMP Walk in incubator 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.
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What is Walk In Incubator :
Walk in Stability Chambers are specially designedequipment for the testing of products and also to test Microbiology study, environmental test , Research and development etc which enables you to tweak parameters like temperature to conduct a thorough check over varied conditions.
- Use of the Walk in Cooling inubator :-
It help for the testing of drugs in varied conditions of temperature,. They are also used to check for how long the product will be efficient to use.
- Working principle of Walk in Incubator :
The Walk in Incubator consists of motor and blower arrangement for air circulation to achieve uniform temperature across the working area. It is a well-insulated double walled chamber and can maintain the temperature as per the set point on the controller within the specified limits.
- What is the Walk in cooling incubator :
ICH Guidelines , WHO Guidelines, cGMP guideline for shelf life study. - What is the difference between cooling incubator and walk in cooling incubator?
- In cooling incubator you need to stand in front of the chamber and open the door to load or unload the sample .
- In walk in cooling incubator , 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 incubator is bigger version of the incubator.
- Normal cooling incubator comes around max size upto 3000 Litres. Hamco Walk in cooling incubator 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) | Storage temperature (C) |
| Microbiology | 22.5 C +/- 2 C | 42.5 C +/- 2 C |
| Microbiology | 27.5 C +/- 2 C | 47.5 C +/- 2 C |
| Microbiology | 32.5 C +/- 2 C | 52.5 C +/- 2 C |
| Microbiology | 37.5 C +/- 2 C | 57.5 C +/- 2 C |
- 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 Walk in incubator with 21 cfr complied compliance.
- 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 Walk in incubator 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. |
- What is Validation of the walk in cooling 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.
- 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.
- Features of Hamco Walk in cooling Incubator.
Hamco is making below said Table series walk in cooling incubator
| Features | What it Includes | Benefits |
| Walk in cooling Incubator | Asthetically look chamber with racks and trays | Precisely temperature controlled chamber |
| 7 Capacitance type display HMI | Big bright display with data logging facility of 30000 data | Easily visible and can save data upto 1 year if the logging interval is 15 Min |
| Standby Refrigeration system | One Main refrigeration system and one standby refrigeration system. | If one system fail , it automatically switch to ther system. Which gives time to repair system without breakdown. |
| Scanner 8 channel (SCN-8) | 8 Temp sensor placed at different location of the chamber | Which monitor the air flow and auto validate the chamber. |
| Alarm Transmission system | 1. External Hooter
2. Mobile alert. 3. Email Alert. |
First alarm will come to display and after 2 Min it will horn external hooter placed at qc room or security and if not attended after 15 min it shoot the alarm on mobile sms and than after 30 Min to email. |
| Authorised door access | Biometric door access | Just place he figure and open the door. No need to put the password and remember password. |
- Hamco Walk in stability chamber Unique Features.
- CE Certified chamber with IP 22 protection safety.
- Precise control of Temperature .
- 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.
- Scanner ( SCN 8) : 8 Temp 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.
- Temperature Range 10.0 °C to 60.0 °C. Accuracy +/- 0.5 °C. Uniformity +/- 1.0 °C
- Temperature Display : HMI Touch screen 4.3” with Colour display .
- Heating system: U shaped Fin type Nichrome wire heater in SS Sheathing.
- Cooling system : Hermetically sealed CFC free Emerson compressor with R 134a refrigerant .
- System is made up of split type condenser unit in well-ventilated area to avoid throw of hot air in the room
- Air circulation : Flange Motor with Impeller and blower for Forced Air Circulation.
- Interior Illumination for working Area.
- Observation window – 300 x 300 mm
- Stainless steel Trays
- Double walled , gap between walls filled with PUF Insulation.
- Double walled with 80 mm insulated modular with panels with easy on-site assembly
- 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.
- Stainless steel Trays. Adjustable Tray Height adjustment.
- HMI Touch screen controller of 4.3”/ 7” with data logging facility.
- Data logging of atleast 1000 data is possible.
- Real time Graph visualisation facility.
- Multiuser with password protection facility.
- High Speed Ethernet based communication.
- Audio/Visual alarm for deviation.
- All operations through a single 4.3”/7” colour Touch Screen
- Over heat temperature and humidity cut off with alarm.
- Low temperature alarm.
- Electrical overload compressor cutoff.
- Time delay for compressor switch on.
- Electrical short circuit breaker.
- Room temperature around machine preferably at 25 degree C.
- Stabilised input voltage of 230V Ac, 50 Hz,
- 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 | TRAY QTY | TRAY SIZE in mm | |||
|---|---|---|---|---|---|---|---|
| Standard | GMP | Cu. Ft | Litres | Chamber size in mtr (HxWxD) | Over All size in mtr (HxWxD) | ||
| HAMCO64S -190 | HAMCO64G-190 | 190 | 5400 | 2.01.362.0 | 2.161.522.16 | 24 | 870X300 |
| HAMCO64S -230 | HAMCO64 G-230 | 230 | 6400 | 2.41.362.0 | 2.561.522.16 | 32 | 870X300 |
| HAMCO64S -280 | HAMCO64 G-280 | 280 | 8000 | 2.02.0×2.0 | 2.162.162.16 | 24 | 870X600 |
| HAMCO64S -340 | HAMCO64 G-340 | 340 | 9600 | 2.42.0×2.0 | 2.562.162.16 | 32 | 870X600 |
| HAMCO64S -428 | HAMCO64 G-428 | 428 | 12000 | 2.42.0×2.5 | 2.562.162.66 | 48 | 725X600 |
| HAMCO64S -530 | HAMCO64 G-530 | 530 | 15000 | 2.42.52.5 | 2.562.662.66 | 48 | 725X800 |
| HAMCO64S -640 | HAMCO64 G-640 | 640 | 18000 | 2.42.53.0 | 2.562.663.16 | 48 | 900X800 |
| HAMCO64S -1070 | HAMCO64G-1070 | 1070 | 30000 | 2.42.55.0 | 2.562.665.16 | 80 | 920X800 |
| HAMCO64S -1785 | HAMCO64G-1785 | 1785 | 50000 | 3.04.24.0 | 3.164.364.16 | 140 | 870X600 |
| HAMCO64S -2857 | HAMCO64G-2857 | 2857 | 80000 | 3.04.85.56 | 3.164.965.72 | 180 | 870X600 |
