Labelling Machine
When your testing requires Stability Chamber, choose “ERFOLG GANAR”, Controlled Temperature/Humidity Solution. Our testrooms feature automated process control, energy efficienc and a vast range of features and options. Every “ERFOLG GANAR” stability/humidity chamber features equipment that reliably produces required conditions, structural integrity that keeps the room working properly through years of demanding test cycles, and measuring/monitoring equipment that precisely records all test data.
ERFOLG GANAR Stability Chamber ensure the Temperature-Humidity is uniform & within range throughout the room. Customer can also avail the option of 4 probe monitoring with data logging, trending & real-time alarms.
They are supplied at customer-site in a prefabric condition & customer need to be check the pass through standard sized doorways for chambers. The installation & commissioning is accompanied with IQ, OQ, PQ protocols & complete documentation.
Erfolg Ganar Provides appropriate stability testing for your products in the most efficient and cost-effective manner, while still maintaining FDA, ICH, cGMP compliance and criteria to meet the regulatory requirements along with the other international bodies such as TAPPI, TGA, JPMMA, MHRA, ANVISA, ASEAN or any of the National Testing Standards.
LONG-TERM, INTERMEDIATE & ACCELERATED STORAGE
STABILITY STUDY | CONDITIONS OF ICH | STUDY PERIOD |
---|---|---|
Long Term | "25°C
±2°C/60%
RH
±5%RH"
"30°C ±2°C/65% RH ±5%RH" "30°C ±2°C/75% RH ±5%RH" "25°C ±2°C/40% RH ±5%RH" "30°C ±2°C/35% RH ±5%RH" |
12 Month |
Accelerated | "40°C
±2°C/75%
RH
±5%RH" "25°C ±2°C/60% RH ±5%RH" |
6 Month |
Intermediate | "30°C
±2°C/65%
RH
±5%RH"
"40°C ±2°C/NMT 40% RH" |
6 Month |
Long Term | "+5°C
±3°C"
"-25°C ±5°C" |
12 Month |
Forced Degradation | "60°C
±2°C/75%
RH
±5%RH"
"80°C ±3°C/85% RH ±5%RH" |
1-5
Days, 45 Days |
Photostability | "Exposure
to
Light
intensity
of 1.2m Lux Hours & UV Light intensity of 200 watt / sq. mtr" |
ICH Q1B |
Technical Specification->
Temperature Range | 10°C to 85°C | |||||
Temperature Accuracy | ± 0.5°C | |||||
Temperature Uniformity | ± 1°C upto 60°C, ± 2°C above 60°C | |||||
Humidity Range/td> | 40% RH to 95% RH | |||||
Humidity Accuracy | ± 2% RH | |||||
Humidity Uniformity | ± 3% RH | |||||
8 Point Temp & Humidity Scanner & Door Access System | YES (Optional) | |||||
Stand By Cooling & Humidity | YES | |||||
Data Logging for 21Day's Backup | YES | |||||
Remote Alarm & Email-SMS Alert System | YES | |||||
Saftey ALarm & Alert | YES | |||||
21 CFR Part 11 Software /Printer | YES (Optional) |
Exterior&
Interior is of stainless steel (SS 304) |
Capacity | Internal Size | External Size | Tray Qty. | Tray Size | |
---|---|---|---|---|---|---|
CuFt | Liter | (H*W*D )Mtr | (H*W*D) Mtr | mm | ||
EGHC1S-M | 1.7 | 50 | 410 x 410 x 300 | 630 x 900 x 710 | 2 | 380 x 280 |
EGHC3S-M | 3.5 | 100 | 600 x 410 x 410 | 1120 x 530 x 780 | 3 | 400 x 400 | EGHC7S-M | 7 | 200 | 660 x 550 x 550 | 1180 x 670 x 950 | 4 | 540 x 530 |
EGHC10S-M | 10 | 300 | 810 x 610 x 610 | 1330 x 730 x 1010 | 4 | 600 x 600 |
EGHC14S-M | 14 | 400 | 810 x 710 x 710 | 1330 x 830 x 1110 | 4 | 700 x 700 |
EGHC17S-M | 17 | 500 | 995 x 710 x 710 | 1515 x 830 x 1010 | 4 | 700 x 700 |
EGHC21S-M | 21 | 600 | 995 x 780 x 780 | 1515 x 900 x 1080 | 4 | 770 x 770 |
EGHC28S-M | 28 | 800 | 1195 x 820 x 820 | 1715 x 940 x 1120 | 5 | 810 x 810 |
EGHC35S-M | 35 | 1000 | 1295 x 820 x 950 | 1815 x 940 x 1250 | 5 | 810 x 940 |
EGHC53S-M | 53 | 1500 | 1500 x 1850 x 540 | 2020 x 1970 x 940 | 10 | 860 x 500 |
EGHC71S-M | 71 | 2000 | 1500 x 1850 x 720 | 2020 x 1970 x 1120 | 4 | 860 x 680 |
EGHC93S-M | 93 | 2600 | 1800 x 2000 x 720 | 2020 x 2640 x 1120 | 4 | 930 x 680 |