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Air Handling Units and the filter configuration is suitably designed to achieve the grade of air as ISO 14644.
Pressure differentials are maintained as per the specified guidelines for the respective dosage forms. Temperature in all areas is NMT 25°C and is monitored manually, daily by Thermo Hygrometer.
| Section | Relative Humidity | Temperature |
| LVP Area | NMT 55% | NMT 23°C± 2°C |
| SVP Area | NMT 55% | NMT 23°C± 2°C |
The Ventilation System Design is based on re-circulation of air. 80% of the air is re-circulated and 20% fresh air is taken in. Air changes in the Class-C area is not less than 50/Hr and for Class-D area is not less than 25/Hr.
All the areas are provided with appropriate ventilation system to maintain the required room condition with respect to the temperature, relative humidity, particulate matter count and potential risk of airborne contamination. To maintain proper Ventilation System in the Plant 29AHUs are provided. All Manufacturing Area meets Class-C requirements.
| S. NO. | DEPARTMENTS / BLOCKS | NO. OF AHU’S |
| 1. | Store | 04 |
| 2. | Production | 16 |
| 3. | QA/QC/Micro | 07 |
| 4. | Packing | 01 |
| 5. | Finished Goods Store | 01 |
| Total | 29 | |
All Ventilation Filters are changed or claimed for maintenance, as soon as the pressure drop across filters deviates from the design range. Such replacement of filter is according to the Standard Operating Procedure. All HEPA filters of Critical and Non-Critical Areas are checked for integrity using PAO Test (Poly Alfa Olefin) and also at the time of replacement / maintenance.
Sterile Water For Injections is used for all manufacturing purposes and Purified water, Water for Injections is used for cleaning of equipments, machines etc. The source of raw water is Bore well. The water system in the plant comprises of the following stages
Raw Water is treated with NaOCl (Chlorination) & then passes through Multi Grade Sand Filter, Sodium Meta bi-Sulphite (SMBS), Softener and treatment with Sodium Hydroxide, Antiscalant and Dosing and then passes through RO-I and stored in SS Storage Tank.
The RO-I permeate water passes through RO-II & collected in Jacketed SS 316 Storage Tanks (Mother Tank, Capacity: 10000 L) and distributed after UV,EDI Exposure in re-circulation Loop.
| Blocks / Area | Storage Capacity |
| Production Area | 10000 Liters |
The Water of injection is distributed to Production Department as well as to Multi Column Distillation Plant through loop system. Water For injection is circulated at a velocity of more than one meter/sec. The required pressure of 1 bar is maintained in the return loop and designed flow rate of water is 1.2 Meter/Sec.
The Distribution Lines are made of SS-316 L, electro polished and Argon welded (Orbital Welding). Required slope of 1:100 is maintained to get complete drainage at any point. Temperature of Water for Injection is consistently maintained at ambient temperature throughout the Distribution System & in Storage Tank and is protected from Microbial contamination by maintaining a constant pressure with continuous turbulent flow circulation within Water Distribution System to Control Biofilms and also we are Sanitizing the system periodically using Hot Water.
The Water System Validation is performed as per the Approved Protocol. The Protocol shall cover the Validation of Water Quality (Raw Water, Potable Water, Purified Water & Water For injection).
Three phases of Water System Validation are performed as per the Approved Protocol. The Protocol shall cover the validation of water quality (Raw Water, Potable Water and Purified Water).
We have RO cartridge of 5μ Micron filtration unit Housed in SS housing and a 30” .
Water sources and treated water is monitored regularly for chemicals, microbiological contamination and contamination with endotoxin to ensure the use of water as per specification appropriate for its use.
Well defined Sampling Monitoring Plan covering all the points on Daily / weekly / fortnightly, Which includes Raw Water Return Loop, User’s points and Storage Tank is followed as per Standard Operating Procedure.
A defined frequency for sanitization of Water System includes Distribution Loop and Storage Tanks is followed as mentioned in Standard Operating Procedure. Sanitization of Purified Water System is done by heating purified water to 80 - 85ºC using steam jacket of Purified Storage Tank during sanitization. Hot Water is circulated at 85 ºC throughout the Distribution Loop covering all the user’s points as per the frequency defined in Standard Operating Procedure. All the devices i.e. RO System, Sand Filter, Cartridges are also treated periodically as defined in Standard Operating Procedure.