PRODUCT DESCRIPTION
- Sterile water for Injections
- Sterile water for Reconstitution
- Sodium chloride injection 0.9% w/v
FACILITY DESIGN
The factory is spread over large area of around 80,000 sq. feet.
- Men
- Materials
- Machines
- Air
- Water
PROVEN QUALITY-TECHNOLOGY
EXPERIENCE-INNOVATION-RELIABILITY
We have the most modern State-of-the-Art production facility with well-integrated systems employing the latest technology to support our entire manufacturing processes with absolute compliance to CGMP to ensure a seamless aseptic production process. The advantage of this contamination-free technology using breakproof plastic containers (LDPE) is a high rate of output and a 100 percent Aseptic, NO leakage product.
We have the most modern State-of-the-Art production facility with well-integrated systems employing the latest technology to support our entire manufacturing processes with absolute compliance to CGMP to ensure a seamless aseptic production process. The advantage of this contamination-free technology using breakproof plastic containers (LDPE) is a high rate of output and a 100 percent Aseptic, NO leakage product.
MANUFACTURING
Dedicated manufacturing and quality management procedures comply with health care grades and regulations, meet WHO GMP, EU Ph., USP testing, and comply with country-specific MOH's stringent regulatory requirements.
- Manufacturing is in the Grade "B" area. The filling is under the Grade "A" area having continuous particle monitoring with a background of Grade "C."
ASEPTIC BFS FILLING
ADVANCED ROTARY MOULD FOR MOST RELIABLE
First indigenously designed, developed and manufactured advanced
Rotary Mould BFS machine for the production of SVP / SWFI in India.
3-IN-1 TECHNOLOGY
EFFICIENT ASEPTIC BLOW-FILL-SEAL (BFS)
The ideal choice for aseptic fully automated Blowing, Filling, and Sealing takes place in a single integrated operation within the self-contained system under aseptic Grade “A” conditions. The filling process, including the dosing system, is empowered with automated CIP / SIP, with maximum filling accuracy and exact individual dosing. This is the most reliable, up to 100 Percent Aseptic Filling method without human intervention.
QUALITY WFI
Quality WFI is generated using the Principle of Distillation employing an ultra-modern Vapour Compression Distillation Unit (VCD), reducing production time and rejection rate. Our WFI quality complies with the latest regulatory requirements of IP, BP, US FDA, EU GMP, and PICS norms.
HIGHEST QUALITY, PARTICLE AND PYROGEN-FREE WFI GENERATED DUE TO A STRONG “DEGASSING PROCESS” TO REMOVE THE NON- CONDENSABLE GASES. CONDUCTIVITY SENSOR TO ENSURE CONDUCTIVITY MONITORING AND “ON-LINE TOC'' FOR PERFECT ORGANIC & INORGANIC CARBON-FREE WATER
WATER SYSTEM
- As per USP 44 - NF 39
- No Multi-Column
- ULTRA-MODERN-VCD SYSTEM
- Quality WFI is generated using the principle of Distillation employing a Vapour Compression Distillation Unit, reducing production time and rejection rate.
- Continuous on-line TOC Analyzer and off-line TOC for Carbon-free water.
- All process piping in direct contact with Feed Water, WFI, and Pure Steam is of SS 316L quality with orbital welding and an internal surface finish of less than 0.5 RA. All other piping is fabricated from SS 316L with argon welding. Standard features compliant with the latest pharma regulatory standards of Conductivity Sensor to monitor the Conductivity.
- On-Line TOC and Off-Line TOC for perfect carbon-free water.
- Robust CIP / SIP Suitable CIP/SIP programs for automatic cleaning, sanitization, and sterilization.
- Storage Tank And Distribution System: To produce sterile pyrogen-free. Storage tank and distribution system are 316L SS pipework; internal surface finish of less than 0.5 RA.
- CLEAN ROOM: HVAC system designed as per International Standards of Clean Room.
- ENVIROMENTAL CONTROL Systems in place.
Our unique resources and world-class equipment allow us to do more for people.
INSTALLED CAPACITY
MAJOR EQUIPMENTS
| Name Of Machine | CAPACITY/ANNUM |
|---|---|
| Double Door Autoclave | 430 liter |
| Vertical Autoclave | 78 liter |
| Stability Chamber ( 300C/ 75% RH) | 600 liter |
| Stability Chamber ( 400C/ 75% RH) | 1000 liter |
| Compressed Air System | 10.2 Bar ( 130 CFM ) |
| Vapour Compression Distillation System ( VCD ) | 3000 LPH |
| Multi-Column Distillation Plant | 800 LPH |
| Manufacturing Tank | 8000 LTR |
| Holding Tank | 500 LTR |
| Rotary Form Fill Seal Machine ( FFS ) | 18000 ampoules/hour |
| Superheated Water Spray Sterilizer | 1,75,000 amp of 10 ml |
SALIENT FEATURES
- Water system is as per USP 44 - NF 39.
- Superior quality WFI is generated employing ultra-modern Vapor Compression Distillation (VCD) System thus reducing production time and rejection rate.
- Aseptic Form-Fill-Seal, 3-In-1 Technology Rotary Form Fill Machines.
- All filling takes place in a single integral operation within the self- contained system under aseptic Grade A conditions.
- The entire process of production takes place in a completely sterilized environment, untouched by human hands which eliminates any risk.
- Online packing operations for sterile water for Injections, sterile water for reconstitution and sodium chloride 0.9 % w/v. Critical Equipment's with PLC Control All PLC and QC Instruments connected through UPS Dedicated Microbiological testing laboratory With maximum filling accuracy and exact individual dosing makes this the most reliable, up to 100 Percent Aseptic, No leakage product.