Piramida d.o.o.
Ampule Boice Kvaliteta Studije sluaja O Piramidi
Quality Quality
How did we manage to solve the vial breakage problem?
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Piramida – guaranteed top quality levels!

Constant rising of quality levels of our products is one of our main characteristics, and as such is recognized by our customers. In our company, we take great care of our quality levels, and we are proud to be in position to offer only the highest quality product.

What is the way Piramida succeeds in achieving top quality levels for its products?

Modern technology which fulfills existing standards as well as offering capability for production of top quality level products

Experience and knowledge gained through almost 60 years of Piramida's existence, which are daily deepened and improved upon. Production is in our state-of-the-art plant where new generation heat-treatment machinery shapes final product.

Ampoules and vials are produced at the most modern production line machinery (Moderne Mecanique MM-30 LA-502, S.P.A.M.I. lines 3BS and BZ-16).

The production lines have built-in parameter control units. Process control uses optoelectronic system for complete control of dimensional and visual parameters, in order to assure that the product fits the standards as well as user requirements.

Properly equipped production space ensures and guarantees a clean environment in production. The process of packaging the product is done in Clean Rooms which fulfill the requirements of ISO 14644-1 class ISO-8 standard (employees are required to use disposable shoes, caps, gloves and outer wear clothes).

High standards in order to fulfill the demanding requirements of customers from pharmaceutical industry

  • Quality management system at Piramida d.o.o. is in accordance with requirements of international standard ISO 9001 (certified in year 2002), and environmental management is in accordance with requirements of international standard ISO 14001 14001 (certified in year 2003.). Production and quality control processes are guided by GMP standard, since they have to fulfill high standards of pharmaceutical industry customers.

  • Understanding of customer requirements during business process is ensured by our openness through multiple communication levels. In cooperation with us, you have a partner who is willing to listen and capable of offering the optimal solutions.

  • Employee education is one of important factors that influence satisfaction of our customers and their requirements.

  • Constant improvement of efficiency of quality control and environmental control systems is also reflected in our company's policy of quality and environment management, which forms the foundations of Piramida d.o.o.

Our system of quality control minimizes the possibility of mistakes

Entry control of raw materials

Our products are made from neutral borosilicate glass tubes which completely fulfills the pharmaceutical industry standards for packaging medications. For snap cap vial marking (OPC, CBR), code rings (CR) and screen printing, we use the highest quality paint. We do entry control of all raw materials before they are used in our production process.

For every shipment of raw materials our suppliers provide us with Statement of Quality, which we can upon request forward to our customers.

Process and final product control

The high quality of delivered product is guaranteed by our production process control system, which through use of optoelectronics controls dimensions and visual characteristics of the product.

Inside our control laboratories we are checking physical and chemical properties of our finished products using state-of-the-art measuring and data analysis equipment. If at any point we deviation from required standards is detected, the product is tested again, on many times bigger sample.

All the results from tests are securely stored and are available for customer inspection.

With every delivery of our product we add Statement of quality for that series of product.

All of the above mentioned produces and guarantees the quality levels that are in accordance with international standards and regulations, as well as our customer requirements.

Traceability

Physical samples of every produced series as well as lab testing results for each series are kept for 5 years.

Certificates for quality control management and environmental management systems

ISO 9001
Quality control system
ISO 9001:2008
Successfully performed recertification audit according to ISO 15378:2015 standard
ISO 14001
Environmental management system
ISO 14001:2004
Čista soba - ampule
Clean room – ampoule production
Čista soba - bočice
Clean room - vial production


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