Quality Assurance

At Atec, quality means delivering solutions that improve the needs and expectations of our customers.

Customer satisfaction is a key success factor for ATEC Pharmatechnik. It represents both the quality of our customer relationships and the quality of our services. The highest standards of quality require customized product solutions based on the specific customer requirements right from the start. For this, Atec includes the customer even before the equipment order to ensure that machine performance meets or exceeds the required product quality.

Our service portfolio includes feasibility studies, process analysis skills, qualifications, and also a fast and reliable After Sales team who can advise our customers on all issues relating to maintenance and spare parts.

Feasibility Studies & System Optimisation

The expertise of our engineers is available in the earliest stages of system development. Due to our many years of experience in processing sterile components, we know that every project is unique and must be designed individually. That is why we support you in:

  • the design of process vessels through capacity analysis
  • the determination of media usage (e.g., process steam, WFI) through media consumption analysis
  • the analysis of contamination-critical and process-relevant parameters (e.g., residual moisture, particles & homogeneity of silicone layer)
  • the economical, technical, and spatial optimization of your system designs and user requirement specifications

Quality Assurance, Qualification & Validation

We make sure that the systems and processes comply with the design specifications and that they meet the user requirement specifications reliably and in the long term. Atec Pharmatechnik provides qualification protocols, supports with the performance qualification and carries out qualification-tests.

As an ISO 9001 certified company, we organize ourselves with SOPs (standard operating procedures), which are documented and executed in a customer-specific and GAMP-compliant manner in the Atec Standard Documentation Package and in accordance with the Atec Standard Testing Matrix.

  • The installation qualification (IQ) verifies the correct installation in accordance with the design specifications
  • The operational qualification (OQ) verifies the correct functioning in accordance with the functional specifications
  • The performance qualification (PQ) verifies the long-term nature and reliability of functioning in accordance with the user requirement specifications

Quality Certifications

The implementation and ISO 9001 certification of our quality management system is one of our milestones.

Atec`s ASME certification enables us to market Atec products worldwide and to meet the highest international safety standards.

  • Design Qualification (DQ)
    Verifies that the proposed design fulfills the design specification.
  • Installations Qualification (IQ)
    Verifies correct implementation of the design specification.
  • Operational Qualification (OQ)
    Verifies correct functionality of the equipment.
  • Performance Qualification (PQ)
    Verifies that the equipment performs correctly under operating conditions.

Project Implementation

DQ, IQ/OQ and PQ are an essential part of quality assurance throughout our equipment validation.