Perfektüp Quality System
Compliance with the highest standards during the entire workflow
Tubettificio Perfektüp has adapted its production processes to the needs of its major customers: pharmaceutical companies. As a result, the Tubettificio's corporate mindset is focused on the highest standards of quality and efficiency.
The internal Quality System is based on ISO 9001:2015 and Good Manufacturing Practice standards. These two standards are the guidelines of the company's internal processes and activities: from the development of new solutions to the delivery of finished products and their sterilization, if required.
ISO certification issued by DNV GL Business Assurance in 1999 and periodically renewed
DMF Type III for the production of collapsible aluminium tubes registered with the FDA (Food and Drug Administration)
Validation by the Vendor Inspection Group (within AICQ), joined by more than 60 Italian pharmaceutical companies; inspections from qualified Italian and international customers.
A Quality System aiming to the Highest Standards
The focus is on product control and compliance to procedures, with the support of a powerful computer system dedicated to the traceability of procedures and the creation of workflows that allow risks to be reduced and business processes to be kept under real control.
The effectiveness of the Quality System guarantees at all times:
- the use of approved materials;
- the absolute quality of the product;
- printing the product according to specifications;
- full traceability of each individual batch;
GMP (Good Manufacturing Practices)
In addition to covering the areas governed by the ISO EN 9001 Quality System, Perfektüp Tubes guarantees all the specific aspects required for the production of packaging for the pharmaceutical sector.
The production environments are designed to ensure product hygiene, avoiding any kind of contamination.
Periodic product and environmental analyses have been carried out to control microbial and particle contamination, according to a precise internal protocol. The data and results from these analyses are summarized and evaluated in a specific document. All critical operations are identified and managed by carrying out a risk analysis: line cleaning, end-of-line checks and sampling. The entire production process up to batch release is managed and tracked by a specific workflow.
Quality Control Laboratory
The Quality Control Lab repeatedly carries out spot checks; aluminium tubes must undergo several kind of stress tests to verify their strength and reliability, such as conductivity, porosity, viscosity and others.
Discover some of them by watching the video gallery.
Use of approved materials
Tubettificio Perfektüp can guarantee the exclusive use of customer-approved materials in compliance with current regulations. Perfektüp's Quality Control can provide all up-to-date documents concerning the individual materials used in the production process, which are made available to customers via the Perfektüp online portal.
For the supply of raw materials, Perfektüp only uses qualified suppliers who can guarantee the necessary requirements and who are strictly evaluated on the basis of their service and the quality of their products. For the most critical materials, acceptance checks are carried out involving special tests both in the laboratory and in production; these are approved through strict quality control, which is also managed with a special workflow.
In-depth knowledge of compliance regulations
The pharmaceutical sector has to follow very strict compliance lines, based directly on the regulations governing the pharmaceutical market at national, EU and international level.
Primary pharmaceutical packaging is an integral part of the pharmaceutical product, and as such must be aligned to the same level of quality and compliance. Heir to more than 90 years of experience working alongside major international pharmaceutical companies, Tubettificio Perfektüp's Quality Assurance is also able to assist you in finding and cataloging the documents and certifications required to meet compliance criteria.
Information Technology at the Service of Quality
The batches of materials used in the production of aluminium tubes are recorded in the computer system to guarantee the traceability of each production order. This data can be recorded in the Certificate of Conformity, which is made available to customers in digital format or, on request, on paper. These documents can also be easily found in the Perfketüp online portal, which customers can access via login. The information systems comply with the strictest cybersecurity and data protection requirements.
A highly trained and skilled team at any stage of workflow
All the staff at Tubettificio Perfektüp have been trained to carry out their tasks with a 'mindset' marked by the high quality standards required by the pharmaceutical world. In this context, Quality Control team plays a fundamental role: among its tasks, in fact, is that of spreading the 'quality culture' among its colleagues, through dissemination actions and actual training seminars held in the plant's internal classroom.
Finished product testing
The Quality Control Laboratory performs strict tests to check the compliance of products to the highest standards and requirements
Controls during production
A highly trained staff carry out spot checks during the various stages of the production process
Sterilization by irradiation
We can supply sterilized tubes for irradiation; we manage the shipping of the product and the follow-up of the entire process.
