Services

Conceptual, Basic and Detailed Designing

We have an expert technical team in the ‘cleanroom designing’ of any forms of medicine and medical equipment production line.

In the conceptual design phase, we design the initial plan based on needs assessment, production conditions and limitations, as well as the GMP standards. After receiving approval from the relevant regulatory body, the basic and detailed design phase begins. In this phase, our engineers design mechanical and electrical installation based on the latest standards and guidelines.

Therefore, in a design project, all the plans required for the implementation of the cleanroom are prepared.

Cleanroom Implementation

At first glance, the cleanroom implementation may not be very complicated and it looks like other structures. But due to sensitivity of pharmaceutical and medical equipment production, cleanroom implementation is facing many challenges. Therefore, cleanroom implementation requires a combination of pharmaceutical, civil, mechanical, electrical, industrial, and computer knowledge.

Keyfiat Pooyan uses the most experienced and professional people in various specialties to implement cleanrooms with all classes of cleanliness. In addition, a lot of experience in design and qualification has made the executive team aware of all the details and finally the cleanroom will be implemented with the highest quality.

Furthermore, our technical team is ready to counsel and modify old cleanrooms that are inconsistent with the new guidelines.

Consulting and Supervision

Despite the enough experience of Keyfiat Pooyan in the implementation of turn-key cleanroom projects, we work as a consultant and supervisor in many projects. In monitoring and consulting projects, we are responsible for monitoring the project implementation process in terms of GMP, selecting the executive team, managing materials and costs, and providing periodic reports.

Balancing and Pressure Adjustment

One of the problems of pharmaceutical and medical equipment companies is imbalanced conditions in cleanrooms or low stability of balance conditions, which due to the high importance of pollution control and stability of clean conditions, sometimes this issue becomes a critical problem.

Balancing is actually creating and stabilizing clean conditions, air pressure difference, and environmental conditions (temperature-humidity) in the rooms.

Due to extensive and advanced research on this issue, we have been able to create scientific and practical methods of finding the best balance conditions by using the analysis of air flow in the air conditioner, channels, and rooms, computer simulations and the use of software to solve complex equations.

Cleanroom Qualification

According to the principles of GMP, annual qualification of air conditioners and cleanrooms, water system, equipment and machines is necessary in pharmaceutical and medical equipment factories.

Qualification tests are performed in four stages (DQ, IQ, OQ, PQ) and based on the latest international standards and criteria such as ISO, WHO and EUGMP. Qualification tests can guarantee the correct functioning of the system and as a result preserves the quality of the products and the health of the personnel. In addition, conducting the qualification tests can reduce the overhead costs and increases the profitability of production by increasing efficiency and reduction of wastes.

Keyfiat Pooyan conducts these tests using the best and the most accurate devices and equipment, and if there are possible problems as a result of the tests, it provides the best solutions in order to solve the problem and reach the desired conditions.

It should be noted that the CEO of this company has a certificate of competency in qualification from MakroTest Turkey (approved by the European Union and WHO) and has held many teaching courses in this field.

Temperature Mapping

One of the requirements of the operation of warehouses and other storage spaces (such as refrigerators and quarantine rooms) is to carry out temperature mapping to ensure that all the desired area has optimal temperature and humidity conditions for storing products.

One of the specialized activities of Keyfiat Pooyan is to carry out temperature mapping in warehouses, cold rooms and product storage areas. In the process of temperature mapping, we provide detailed reports and documentations based on statistical analysis and also provide practical solutions to resolve possible discrepancies.

Computer Simulation and Optimization

Today, the increasing usage of technology has been increased the speed, accuracy and quality of work. The technical and engineering team of Keyfiat Pooyan are able to optimize and troubleshoot the systems in the best way by using computer simulation AHU systems, air ducting network and cleanrooms. One of the prominent advantages of using computer simulation is reduction the costs of modification and repairment, finding optimal conditions, and finding possible defects in the design.