1. What is Bacteriological Incubators :
- Bacteriological Incubators as it name suggests used for bacterial culture growth. Here we keep bacterial plate inside the Bacteriological incubator for monitoring its growth. The temperature range in the Bacteriological incubator is Ambient + 5 C to 60 C .
2. Use of the Bacteriological Incubators :-
- Bacteriological Incubators are used to test tissue culture growth, storage of bacterial cultures and incubation. It also helps in determining levels of organic matter and nitrogen in waste water samples.
3. What is the Bacteriological Incubator Guidelines :
ICH Guidelines , WHO Guidelines, cGMP guideline for shelf life study.
4. Storage Conditions :
5. Storage temperature (C) 6. Set temperature (C) 7. 20 C to 25 C 8. 22.5 C 9. 25 C to 30 C 10. 27.5 C 11. 30 C to 35 C 12. 32.5 C 13. 35 C to 40 C 14. 37.5 C
- 15. 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
- 16. 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.
17. Terminology 18. Full Form 19. Use 20. DQ 21. Design Qualification 22. This confirm that How de design the chamber and why certain component has been selected. 23. IQ 24. Installation Qualification 25. This confirm How to Install the equipment by checking all the component Make, sl No and certificate, Preinstallation requirement and Utilities. 26. OQ 27. Operational Qualification 28. This confirm the operation wise checking of all the paramenter of the equipment. 29. PQ 30. Performance Qualification 31. This confirm the performance qualification of the stability chamber.
32. 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.
33. 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.
34. Type of Bacteriological Incubators.
- Hamco is making below said Table series Bacteriological Incubator
35. Series 36. What it Includes 37. Benefits 38. PID Series 39. Hamco 41 Series 40. Chamber Only. No USFDA, WHO , GMP Compliance 41. Normal series 42. Consist of Chamber (Hamco 41 series) + RS 485 communication Card (PCI-1) + Data Logger (RCR-11 + SOFTD-21 (Desktop browser based Software Part 11 21 CFR ) 43. WHO Complied 44. ECO Series 45. Consist of Chamber (Hamco 41 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 ) 46. WHO, USFDA, GMP Complied 47. Premium Series 48. Consist of Chamber (Hamco 41 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 ) + SCN-4 ( 4 Temp) + VAL ( Validation) 49. WHO, USFDA, GMP Complied.
50. Redundency for Failure of any component for Long studies.
51. Scanner for Auto validation of the chamber.
52. Mobile and E-mail alert for critical alarm to deliver on mobile or e-mail.
“HAMCO” Lab Incubators are designed primarily to meet the requirements for tests of Biological Oxygen Demand / Biochemical oxygen demand and equipped for controlled incubation and storage of sensitive samples / cultures, vaccines etc. . These incubators are designed to meet the testing challenge of pharmaceutical competitive research field and enhance the scientific efforts of educational institute and organisation.
HAMCO Make GMP Lab Incubator is 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 Ambient + 5.0 °C to 60.0 °C. Accuracy +/- 0.1 °C. Uniformity +/- 1.0 °C
- Temperature Display : Digital LED 3 ½ digit, Resolution 0.1 deg C
- Heating system: U shaped Nichrome wire heater in SS Sheathing.
- Air circulation: Flange Motor with Impeller and blower.
- Interior Illumination for working Area.
- There will be two nos of blower from 450 Ltr Onwards.
- Double walled, gap between walls filled with PUF Insulation.
- Standard Model: Stainless steel Mirror polished chamber and heavy gauge 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 silicone 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.
- Temp. Sensor: PT- 100.
- Dedicated safety controller with separate sensor to cut off the supply in case of overshoot and undershoot of temperature giving audio visual alarm. ( Optional)
- 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 present temperature.
- PC Interface communication card with RS 485 for temperature and humidity control system ( Hardware only) ( optional)
- Over heat temperature with alarm.
- Electrical overload compressor cut-off.
- 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, and 20 Amps.
- Water drains 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.
|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|
|HAMCO41S -1||HAMCO41 G-1||1||20||30x30x30||60x95x82||1||42||67||230,50||500|
|HAMCO41 S-1.5||HAMCO41 G-1.5||1.5||45||35x35x35||60x95x87||1||50||77||230,50||600|
|HAMCO41S -3||HAMCO41 G-3||3||90||45x45x45||60x95x97||2||70||100||230,50||800|
|HAMCO41 S-4||HAMCO41 G-3||4||120||45x45x60||60x95x112||2||85||120||230,50||1000|
|HAMCO41 S-8||HAMCO41 G-8||8||200||60x60x60||80x110x112||2||105||140||230,50||1200|
|HAMCO41 S-12||HAMCO41 G-12||12||324||60x60x90||80x110x142||3||120||155||230,50||1400|
|HAMCO41 S-16||HAMCO41 G-16||16||450||60x60x125||80x130x162||4||140||175||230,50||1500|
|HAMCO41 S-21||HAMCO41 G-21||21||600||60x80x125||80x130x182||5||165||205||230,50||1750|
|HAMCO41 S-28||HAMCO41 G-28||28||800||80x80x125||100x130x197||5||205||250||230,50||2000|
|HAMCO41 S-34||HAMCO41 G-34||34||1000||80x80x155||100x130x207||5||250||300||230,50||2200|