Radioisotope Development & Production For Industrial & Medical Applications

parsisotope

Introduction


Today, in the era of nuclear science and technology, mankind is living in a quite different world to his ancestors.The livelihood and welfare of humans are now intermingled with nuclear technology and its achievements.
Iranian scholars have always been pioneers in the advance of scince and well-being of the human societies, as it is found in the long lasting poem:

If you split a particle                     you find a sun hidden inside

Relying on the foregoing briefs, PARS ISOTOPE Co. ( PICo) was founded and is mainly involved in:
“Production and development of various radioisotopes, associated equipments, and related services in the fields of medicine and industry”

The company has so far tried to supply viable products /services by employing the state-of-the-art technology, professional manpower, the highest qualitative standards and has committed itself to technically updated science and culture of radiation application both at local and global markets.

Based on humane and national values as well as International Standards, our company approach in this business is to treat our consumers as the most precious wealth and hence, urges to meet all requirements in favor of total cost reduction in order to uplift societyʼs health level. Moreover, this would also entail empowering related plants, consumers satisfaction and realizing Companyʼs progress according to its following key motto:

 

“A New Horizon of Life ”

 

There are many fields of activities adopted by the PICo. as following:

  • Industrial production of various radioisotopes used in medicine and industry;
  • Manufacturing of industrial/medical radiation sources and sealed sources;
  • Development of radiopharmaceuticals in the field of diagnosis and treatment;
  • Invention and optimization of advanced methodologies in production of radioisotopes;
  • Establishment of viable systems of radioisotope separation;
  • Design and production of personal/environmental surveillance systems, inspection kits and radiographic apparatus.

 

 

Values at Pars Isotope:

• Efforts to reduce the suffering of patients by providing new and high quality products

• Respecting the rights of customers and stakeholders

• Commitment and accountability

•Teamwork

• Integrity and honesty

• Continuous learning and improvement

 

Missions:

  1. Promoting the overall health of the human community by timely diagnosis through the production of effective diagnostic products
  2. Reduce the suffering of certain diseases, especially cancer, by production of low-cost and effective therapeutic products
  3. Creating constructive interaction between the company and the nuclear research centers in all areas
  4. Allocation of resources for the continuous improvement of knowledge, culture, creativity and accountability of manpower, quality and quantity of products and value chain of the company
  5. Reducing costs, promoting productivity and creating wealth in the country's industries through the development and application of nuclear technology
  6. Self-sufficiency, elimination of dependence and the realization of a resilient economy through the application of creative solutions and the crossing of constraints by relying on indigenous knowledge
  7. Production of products and provide services for the technical engineering of nuclear medicine and industrial fields to meet the needs, to maintain market equilibrium and to satisfy the interests of domestic consumers.

 

Organization chart

 

Integrated Management System Policy

 

Parsisotope Company, as the sole producer of radiopharmaceuticals and industrial radioisotopes in Iran, is committed to manufacturing products and offering best quality services in a safe and secure place for its stakeholders, with the least damage to the environment, and in compliance with national and international standards in a dynamic and innovative work environment.

To this end, all my dedicated and conscientious colleagues and I in the company strive to exploit national and international experts and specialists to implement GMP-PIC/S, GMP-WHO,ISO 9001:2008, ISO 14001:2004, 18001:2007   OHSAS principles and requirements in an integrated, efficient, and effective manner. To ensure the safety, quality, and effectiveness of products and services, we all feel obliged to implement all aspects of the system policy including as follows:

  1. Upgrading human resources’ knowledge, skill and organizational culture as the most significant assets with the aim of rendering the company into a learning organization,  that is, a knowledge-creating organization;
  2. Shifting from satisfied stakeholders to enthralled stakeholders through acknowledging and fulfilling their needs;
  3. Promoting the quality of products, manufacturing new products, and constantly improving the effectiveness of the management system and all the processes involved, ranging from supply chain to storage and distribution with the purpose of accomplishing global standards and raising the international market share;
  4. Capitalizing on knowledge management and risk management as two empowerers, taking advantage of today’s technology and supplying the required resources to adhere to relevant rules and regulations;
  5. Developing and establishing infrastructure and optimum workplace and employee welfare with the aim of producing and offering services with the help of exuberant staff in a safe place and with an approach to prevention with the least risk involved.

CERTIFICATE


Iso 9001 : 2008

Pars Isotope has implemented and maintains a Quality Management System

 

Through an audit, documented in a report, it was verified that the management system fulfills the requirements of the following standard:

ISO 9001 : 2008

 

Date of Certification: 2015-02-09

Valid from 2015-02-09

Valid until  2018-02-08

Registration number: DE-40150019 QM

GMP CERTIFICATE

This is to certify that :

The above-mentioned manufacturer is authorized to produce pharmaceutical products in the ISLAMIC REPUBLIC of IRAN.

The manufacturer plant is subject to regular GMP inspections   (at suitable intervals) by the Deputy Ministry for Food and Drug. 
The manufacturer complies with Good Manufacturing Principles for pharmaceutical products which are currently in force in the
 ISLAMIC REPUBLIC of IRAN and the plant was established according to the Word Health Organization code.
 
 Likewise, the production lines including; Radiopharmaceuticals and Radiopharmaceutical cold kits

Packaging

All radiopharmaceuticals are classified as hazardous materials and need packaging with a UN marking. Radiopharmaceuticals can be packaged in a variety of configurations and shipped under strict environmental controls. Using highly trained and specialized team, PARS ISOTOPE has developed special packaging designs for the delivery of its products. All radiopharmaceutical packagings submit to the national and international regulatorys authorities for the transportation of radioactive products. The packaging which is designed at PARS ISOTOPE had passed all the standard quality control tests by the National Radiation Protection Department (NRPD) and approved as type A radioactive packaging. These packagings are in a metal or plastic drum with light preservative polymer as holder of lead shield containing radiopharma- ceutical. The packages are marked with a yellow ΙΙ category labell which includes the type of radiopharmaceutical, the activity and transport index (TI). Radiopharmaceuticals after placing in packages are sealed, labeled and shipped to the customers.

 

Radiopharmaceuticals Quality Control Department

The PARS ISOTOPE quality control management is equipped with the modern analytical instruments complying to Good Laboratory Practice( GLP) which conducts the control exper- iments in accordance with the applicable pharmacopoeial monographs. This management consists of raw material control lab, prod- uct control lab, biological and microbiological control lab, chemistry and radiochemistry lab, instrumental analysis lab and IPQC. In these labs, certified analysts carry out raw material and packaging analysis, bulk and finished product analysis and review the batch documents. Highly trained and qualified personnel perform the tests based on pharmaco- poeial monographs making this management as a national reference in the radiopharmaceutical quality control field.