Located on a hilly area, on the slope of Arjuna mountain in East Java, the factory is surrounded by green environment providing pleasant and healthy working atmosphere.
Contact Address :
Jln. Stadion No. 1 Pandaan – 67156, Jawa Timur
PO.BOX 18 – Indonesia
Phone : (62-343)-631-575
Fax : (62-343)-631-576
E-mail : firstname.lastname@example.org
Quality Management System
A stringent quality management system is indispensable to the quality assurance and good manufacturing practices in the manufacture of parenteral solution. By quality assurance, it means that WIDATRA has to be fully certain and assured that each and every single container of parenteral solution that it delivers to buyers are thoroughly sterile, pyrogen-free, and free of any particulate matters.
As we approach the WIDATRA plant site of more than 32,500 sqm in Pandaan, East Java, we are made aware of why it was built in that location. The site is located strategically in the hilly region of Pandaan where natural water springs provide ideal sources for water as the primary starting material for the manufacture of parenteral solution.
Getting inside the manufacturing plant, we are struck by the many layers of bio-security rotocols that are rigorously applied to ensure a pyrogen-free environment. Visitors to the plant have to wear sterile outer garments, where as workers within the facilities wear even more protective clothing’s made of non-linted material (garments that are not made of woven threads).
Natural water is purified and treated with several steps of purification and distillation processes; and from the time water is collected in the main receiving tanks, it will undergo a series of processes the include sterilization, mixing and bottling within a completely enclosed environment in which there is not a single human-hand intervention involved in the entire process, until the parenteral solution is safely contained inside the plastic bottles.
WIDATRA has met the standard requirements of the ISO9001-2008 certification, and aims to achieve the PIC/S (pharmaceutical Inspection Convention Scheme) certification in 2010.
Even then, the aseptically filled bottles are then sterilized in a sufficient time and sufficient heating temperature in such a way to ensure that the products will be sterile and also pyrogen free.
The sterilized goods then will be checked for any leakage possibility with “leakage tester”. And then it will go for a labeling and final packaging process.
To sum up the manufacturing process, natural spring water goes through a Multistage Distillation Units to produce the so-called Water-for-Injection (WFI) to standard requirements. Cleaning-in-Place and Sterilization-in-Place mechanisms run automatically on every equipment that comes into direct contact with the WFI. The final solution after being mixed with the proper ingredients is then packed automatically in an enclosed system known as the Blow-Fill-Seal (BFS) process. Throughout all this, a Quality Management System undertakes an in-process, room-monitoring and end-process controls via consecutive sample checks to ensure that the final products meet the required high quality standards prior to shipment.
WIDATRA adheres Quality Assurance, Good Manufacturing Practice, and Quality Control, into its quality management system in line with international best practices. The assurance of WIDATRA’s quality infusion solution begins with the prime location of its manufacturing facilities.
Located strategically in an industrial area at the foot of Mount Welirang, approximately 45 kilometers south of Indonesia’s second largest city, Surabaya, in East Java, WIDATRA has its entire production activities. This area provides ample source of clean water that originates from the numerous water springs.
Within such an ideal location and conducive environment, WIDATRA has established its manufacturing facilities on a 32,595 square meters of land, of which 9,021 square meters are occupied by the buildings that comprise of the factory buildings, warehouses and utilities.
Being aware of environment and safety at the work place, a Health, Safety, and Environmental protection system has been implemented within the manufacturing site. The system includes waste treatment and disposal, as well as safety measures and protections. Complementary to this system, an intensive pest and rodent control measures are taken to ensure a clean and healthy environment throughout the manufacturing site.
Besides the clean water supply and healthy environment, the quality assurance system of WIDATRA also extends throughout the manufacturing process, whereby quality control is rigorously applied from the moment the raw material is unloaded in the warehouses, to the time they are moved across the production lines under strict supervisory control.
The use of top-of-the-line equipment and processes will ensure both sterile and pyrogen-free infusion solutions. First and foremost in the manufacturing process is the Multistage Distillation Units in which the Water for Injection (WFI), the basic form of infusion solutions, is made to comply with the required quality. Other key factors of the manufacturing process are the Cleaning-in-Place and the Sterilization-in-Place methods that are automatically applied within the entire production equipments that come into direct contact with the solutions. These methods have been proven and validated to be extremely effective in the prevention of contamination and maintenance of high quality standards.
Once the solution is ready, primary packaging process takes place. The molding of plastic bottles, solution filling and closing of the bottles are carried out without human interference through a closed system known as Blow-Fill-Seal (BFS). Since manual handling is not required, this system greatly minimizes the possibility of contamination.As one of the important aspects in the Quality Management System, Quality Control is applied evenly throughout the process. This includes the in-process control, room monitoring, and end-control to confirm that the manufacturing processes are carried out as expected, and the final products meet the required quality prior to shipment.
WIDATRA’s meticulous and precise manufacturing process could not be undertaken without a strong technical support. This includes the implementation of a Quality Management System, a process for a continual improvement that is constantly enhanced through regular self-inspection. A measure of a successful Quality Management System application is the documentation process that leads to traceability of the entire manufacturing process. Technical support from Japan and Germany covers engineering, product and process development as well as information technology.