Infrastructure

Manufacturing Facility

Global Pharmatech has invested in a plant which spreads across a 5 acres plot, in Hosur, Tamil Nadu (outskirts of Bangalore). Two separate units are incorporated in accordance with international standards. Unit 1 consists of an Ampoule line, a Vial line, and a LVP line. Unit 2 consists of an integrated ampoule line and an integrated glass vial line with 100% visual inspection and a Pin Hole detector for ampoules.

Unit 1

Ampoule Line: It is well-suited for smaller batches and short campaigns. The line includes the following features:

.       Fill volume: 1 to 10 ml

.       Batch size: 10 to 100 liters

.       Aseptically filtered with 0.2 micron filters

.       Terminal Sterilizer in place

.       Speed: 120 ampoules/min (Each machine)

.       Annual Capacity: 30 million ampoules

.       Manufacturer: Cad Mach 

Vial Line: It is well-suited for quick changeovers and small batches is equipped with the following features:

·         Fill volume: 2mL to 100mL

·         Batch size: 100 liters  to 1300 liters

·         Aseptically filtered with 0.2 micron filters

·         Speed:120 vials/min (2mL to 10mL)

·         75 vials /min (30mL to 50mL)

·         40 vials/min (100mL)

·         Annual Capacity: 20 million vials (2mL to 10mL)

·         120 million vials (3mL to 100mL)

Unit 2

IMG_8269_1

Ampoule Line: It was approved by EU in 2010 (under renewal), includes the following features:

•         Integrated washing, sterilization, filling line

•         Fill volume: 1mL to 5mL

•         Batch size: 100 liters  to 400 liters

•         Aseptically filtered with 0.2 micron filters

•         Terminal Sterilizer in place

•         Speed: 250 ampoules/min

•         Annual Capacity: 72 million ampoules

•         Manufacturer: Petals

IMG_8297_1

Vial Line: The EU GMP certifiable Vial Line is equipped with the following features:

•         Integrated washing, sterilization & filling line

•         Fill volume: 2mL to 100ml

•         Batch size: 100 liters to 400 liters

•         Aseptically filtered with 0.2 micron filters

•         Speed: 150 vials/min

•         Annual Capacity: 36 million vials

Both the ampoule line and vial line were upgraded in 2013 to incorporate RABS (Restricted Access Barrier System) and ensure Grade A continuity in all critical areas.

 

Sterilization Methods

The facility is capable of manufacturing both aseptically filled and terminally sterilized products.

Environmental Monitoring

Particle counters have been installed at point of filling in both lines for continuous monitoring of non-viable particles. In addition, Metone Sequential Particle Counters have been installed for monitoring non–viable particles in other sections of Class A area.

Automatic Leak Test & Inspection Facility

Global Pharmatech has a state-of-art modern machine to conduct automatic leak test and inspection of both vials and ampoules. This machine ensures that the final product is free of defects that could compromise sterility.

Pin Hole Inspector

A special feature of the ampoule filling line is the High Voltage Leak Detection Tester. It can perform non-destructive seal integrity testing for each glass container without secondary contamination of the products. The unit can detect pinholes as small as 0.5 microns.

•         Manufacturer: Nikka Densok (Japan) Pin Hole Inspector

•         Speed: 400 ampoules per minute

•         Function: Perform non-destructive seal integrity testing of each ampoule

•         Detect up to 0.5 micron size pin hole

•         Principle: High voltage

 

Water System

The purified water (PW) and water for injection (WFI) systems are critical elements of a facility manufacturing sterile Injectables. GPPL has a purified water system, supplied by Christ Nishotech, which incorporates UF, RO, and RO-EDI to consistently produce purified water that is free from physical, chemical, and microbial contamination. The PW system has a capacity of 5000 liters of purified water per hour. The system is designed to conform to cGMP, GEP and GAMP requirements and delivers PW as per Pharmacopeia standards.  The WFI system, with a capacity of 1500 liters per hour, produces WFI that meets IP, BP, and USP standards for WFI by a seven- stage distillation process.

Manufacturing Capacity & Capabilities

Unit 1

Small Volume Parenterals Fill Volume Capacity/Month
Ampoule (0.5mL- 10mL)  0.5mL to 10mL  5 Million
Vial (2mL-25mL)  2mL to 10mL

 10mL to 30mL

 50mL to 100mL

2.5 Million

1.3Million

0.4 Million

 

Unit 2

Small Volume Parenterals Fill Volume Capacity/Month
Ampoule (0.5mL- 10mL)  0.5mL to 5mL 7.5 Million
Vial (2mL-25mL)  2mL to 10mL

10mL to 30mL

50mL to 100mL

3.5 Million

2 Million

0.4 Million

Quality

Global Pharmetech’s strength is providing comprehensive service and products of the highest quality and the best yield standards. This is possible due to its uncompromising approach and adherence to strictest of quality procedures and practices. In keeping with the requirements of the customers, its quality assurance department adopts the best of procedures and practices and offers value added service.

It adheres to highest standards of quality by strict compliance to cGMP, WHO-GMP, ISO 9001:2000, as well as good laboratory practices (GLP). Standard operating procedures developed with active support of leading multinational partners like Glaxo SmithKline, Pfizer, Parke-Davis etc and maintain unequalled quality standards at all times. GPPL’s commitment to maintaining quality standards are further strengthened by multinational company audits.

The plant is scrupulously maintained through built-in rigorous Quality Assurance procedures, strict documentation and internal audits. Our superior validation systems result in the production of high quality products at all times. We emphasize greatly on training thereby ensuring outstanding team performance. We have been repeatedly excelling in audits of our multinational partners.

R & D

Historically, GPPL has been a contract manufacturer. More recently, we have started developing sterile liquid injections in vials and ampoules products for India, Semi-Regulated, and Regulated markets.  GPPL has entered into co-development agreements with customers in North America, Europe, South Africa, and Australia. We have introduced a few products developed by GPPL in India and we are in the process of registering these products in other markets.