* A 100% export orianted Unit    (E.O.U.)

* OTC products are devloped
   by :

  • Formulation development
  • Batch scale-up
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Salient features of the facility are :
  • Unidirectional Flow of Men & Materials.
  • High Level of Product Protection from contamination & cross-contamination
  • Upcoming…..Use of gravity/vacuum transfer systems for the product movement and high degree of automation for product & personnel safety.
  • HVAC System designed to meet the cGMP requirements , e.g. Pressure Differentials, Filtration Rating, Temperature & Humidity control.
  • Men - material flow : Uni linear man and material movement for the starting and finished products ensure prevention of mix-ups & cross contamination.
Validation :

validation activity is a journey and not a destination through out the lifecycle of a product, process, equipment and facility. Validations are carried out as per defined procedure for processes, new formulas, changes to the existing procedures. Re-Validations are carried out as per schedule to ensure that the processes are achieving the intended use & of highest quality.

Brief Description of Water Purification System :
The Water Purification System is designed to process and purify the feed water. The system is designed to Supply Water for the following end uses.
  • Purified water for usage in manufacturing processes.
  • Process water for equipment washing and cleaning purpose.
  • Potable water for drinking & domestic purpose.
  • Boiler feed water.
  • Hot water system.

Water Purification System - Process :
The System has been designed to generate Purified Water meeting the specifications and quality parameters as specified in USP.

Incoming raw water is subjected to chemical dosing involving dosing of Sodium Hypochlorite and Poly Aluminum Chloride (PAC). The PAC flocculates the suspended particles thereby clarifying the water whereas it disinfects the incoming water and prevents microbial growth. It also helps to oxidize dissolved ferrous impurities.

Water is then subjected to filtration through Multi Grade Filter, which filters out suspended particulate matter. After this stage, part of the filtered water is supplied.
The system provides for online monitoring of pH & conductivity. The Purified Water is kept under constant circulation through closed loop system, during distribution and storage. The Purified Water is also monitored for the TOC and microbiological & chemical purity. The system is equipped with U.V. lights for ensuring elimination of the dissolved Ozone before actual usage of the Purified Water.
Salient features and system parameters :
  • Reverse Osmosis system.
  • Electro De-ionization system.
  • Ozonation.
  • The Purified Water circulation loops are made out of SS 316L Electro-polished and the joints by Fusion Technology (Orbital Welding Technique).
  • TOC of Purified Water : less than 500 ppb.
  • Conductivity of Purified Water : less than 1.0 µ siemens/cm.

Type of Filters :

  • Multi-grade filter: filled with gravels for filtration of suspended particulate matter.
  • Pre-Filter No.1 of 5 µ porosity and Pre-filter No.2 of 10 µ porosity. Both these filters are placed before reverse osmosis unit.
  • Reverse Osmosis Membrane.
Frequency of Sampling of Purified Water :
Purified Water is sampled from various points as per the authorised SOP per International Regulatory standards. The frequency is to be decided on the basis of validation data and the risk assessment for individual dosage form. Till the system is completely validated and the trend regarding the microbial and chemical purity of the water is established, the sampling is to be carried out everyday from all the user points.

Other important Services :

  • Compressed Air System
  • Steam Boiler & Supply System
  • Captive Power Generation & Supply System (D.G. Set)
  • HT / LT Power Supply

QUALITY : QC / QA

State of the art quality control laboratory for Chemical & Microbial testings.Our commitment is to earn the trust and confidence of our customers every day by delivering Qualitative & Quantitative performance  that always meet regulatory requirements and are of  USP or NF standards.

Capacity & Capabilities :
We offer commercial OTC/Generic finish product & contract manufacturing services as per cGMP practice in solid oral dosages….and having following capacities:
  • Milling and blending: 50 MT per month
  • Tableting: 100 Million per month
  • Encapsulation: Filling: 50 million per month & Gelatin Banding: 50 million per month