Centralized Stability

The 5 state of art, walk-in Stability Chambers at Akums are equipped to conduct stability Studies as per ICH (Q1AR2) guidelines and for assuring quality standards, Akums have Large Stability Chambers comprising – 1 Stability chamber with 100,000 capacity, 3 Stability Chambers with 2,00,000 capacity each and 1 Photo Stability Chamber with 200 Ltr. capacity.

Stability for products is performed at various conditions by maintaining the environmental conditions as per regulatory requirement using number of AHUs, chillers, dehumidifiers etc.

This world class Centralized Stability centre has Independent Quality Control Lab to assure strict regulatory and products, process & parameters compliance under supervision by centralized CQA Team. There is a dedicated QC Department well equipped with highly sophisticated equipments as per CFR Compliance.

Akums’s NABL approved Laboratory is fully equipped for Physical & metallurgical testing, Micro-biological testing, Chemical testing, Pharmacological testing etc. to conduct periodic quality reviews for products, processes and procedures. Equipped with latest instruments like TOCA (Total Organic Carbon Analyzer), 204 HPLC’s, 8 FTIR’s, 2 Atomic Absorption Spectro-Photometers, 5 Gas Chromatography-HS-Auto Sampler with FID, TCD, ECB.

Stability Chambers with following Capacity are installed in the Centralized Stability Study Facility:

Stability Chamber
(Temperature/Humidity)
Capacity
(Liters)
Accelerated Stability Study
(40°C ± 2°C / 75%RH ± 5%RH)
200,000 L
Intermediate / Long Term Stability Study
(30°C ± 2°C / 65%RH ± 5%RH)
200,000 L
Long Term Stability Study
(25°C ± 2°C / 60%RH ± 5%RH)
200,000 L
Long Term Stability Study
(30°C ± 2°C / 75%RH ± 5%RH)
200,000 L
Photo stability Chamber
23°C ± 2°C / 55% RH ± 5% RH
200 L