Facilities

Manufacturing Facilities

We PRG have separate dedicated blocks which have been designed as per EU-GMP requirements to ensure that there is a uniflow of men and material movement along with requisite isolation of operations within these sections.

Our newly commissioned unit is fitted with state of the art manufacturing facility complying all international requirements. Well qualified equipments and instruments installed for products development, manufacturing & testing, instrumentation and all other requisite technologies such as online product monitoring systems, product and process optimization and data logging

Tablet Section

  • Dedicated separate clean area for Wet Granulation and Dry Granulation.
  • Qualified Sifters, Fluid Bed Dryers, Cone Blenders, Lifters, Multimills etc.
  • Fully Automated.
  • All Compressors placed under different clean rooms.

Capsule Section

  • Specially designed facility for low humidity product requirements.
  • Compaction and blending carried out under terminal HEPA.
  • Capsule Filling section fully automated.

Liquid Orals

  • All processes starting from bottle cleaning, washing, Liquid filling, capping and labelling are Performed under Terminal HEPA.
  • Fully Automated qualified equipments.

Dry Syrup

  • Dedicated facility with separate AHU for contamination free blending and filling activities.

External Preparation

  • Physically isolated section with qualified manufacturing vessels(SS 316) under clean room facilities.
  • Filling and packaging operations automated.

Qality Assurance & Quality Control

Our State of the art In-House QC is divided into the following sections:

  • Instrumentation I - Validated Disintegration Apparatus, Dissolution Apparatus, Hardness testing, pH, Polarimeter,KF Titration, Friability, Refractometer and other instruments.
  • Instrumentation II - Sensitive instruments including High Profile Liquid Chromatography and Ultra Violet Spectrophotometers.
  • Chemical Section - All chemical tests and analysis involving reagents. Dedicated fuming hood section.
  • Microbiological Section - With latest BSL Level II compliant Laminar Air Flow and array of autoclaves, incubators, Colony Counters, Microscopes etc.

Engineered Utilities

WHO TRS 1019 Compliant HVAC System.

27 Air Handling Units;Total installed capacity 1,06,370 CFM.

Dedicated AHU for each section. Pressure differentials cascading- No risk of flow reversal and cross contamination.

WHO TRS 970 compliant Purified Water generation System & 24x7 Loop Distribution System Capacity of 2000L/Hour.

EU-GMP prescribed steps of Chlorination, Mixed Sand Filtration, Softening , Activated Carbon Filtration, Double Pass Reverse Osmosis system , Mixed Bed Deionization and UV Treatment.

Additional UV treatment for Loopline.

Phase I, II and Ill validations Completed.

Air compression system from Atlas Copco Contamination free compressed air.

4 level air filtration of 1 micron, 0.1 micron and 0.01 micron filter and terminal oil filter.