Scientific Electronics: Expertise in Aerospace, Hospital and Electronics
Elettronica Scientifica intervenes in all those situations in which air is a critical element, requiring global environmental monitoring that includes the systematic control of microclimatic and microbiological conditions and chemical-physical characteristics.
Engineering
Thanks to the experience gained in the pharmaceutical and health-science fields, Elettronica Scientifica is able to provide specific services for the “local” or extended to the entire process and/or system, involving the accompanying systems and the behavior of the staff. Elettronica Scientifica is able to provide plant engineering consultancy, starting from the preliminary definition of user and regulatory requirements, and assistance that can continue throughout the life cycle of the system:
Support in the construction of treatment plants (filtration, heating, dehumidification, cooling) and air distribution
Support in the construction of production and distribution plants for hot and cold heat transfer fluids
Support in the construction of technological plants (refrigeration plants, heating plants, water plants, etc.)
Revamping and optimization of existing plants
Definition of energy saving or necessary interventions in order to obtain optimal environmental conditions
Definition of the interventions necessary in order to comply with laws or regulations
Technical Support
Within its corporate structure, Elettronica Scientifica has the resources that allow it to provide technical support and assistance.
Elettronica Scientifica is able to provide the following services:
Tab Procedures
Maintenance and calibration of HVAC systems
Replacement of filter systems
Optimization of control computer systems
Elettronica Scientifica is able to constantly monitor the performance of plants and equipment, in order to immediately identify significant changes in performance before they can cause serious problems. The experience of our technicians and the instrumentation at our disposal allow us to guarantee a valid check-up and maintenance activity, verifying and certifying the performance of systems and equipment.
Validation Service
The qualification and certification of laminar flow devices, clean rooms, operating rooms and HVAC systems plays a fundamental role in all those realities where it is necessary to maintain sterile conditions and guarantee defined standards on the chemical and physical characteristics of theair and the rooms served. In this regard, the ISO 11425:2011 standard has defined the qualification of the operating theatre for new buildings and renovations as an essential requirement.
Elettronica Scientifica, thanks to the experience gained over years of testing and certification of systems intended for the pharmaceutical world, is able to offer a complete product (Validation Package), following the customer at every stage of the validation cycle.
The know-how of the staff involved, both in the generation and execution of the protocols and in the field tests, allows us to meet the needs of customers of international importance and subject to the increasingly stringent requirements of regulatory bodies (Ministry of Health, US FDA, European Regulatory Agencies, etc.).
Commissioning & Qualification" (C&Q)
Commissioning & Qualification” (C&Q) s a fundamental process in the design, construction and operation of plants and systems, particularly in the pharmaceutical, biological and food sectors. This process ensures that plants and equipment are designed, installed and operated according to predefined specifications and that they meet quality and regulatory requirements.
Key features of the Commissioning & Qualification service:
Specification:
Drafting of clear and detailed project specifications and functional requirements.
Commissioning Plan:
2Commissioning Plan: Development of a detailed plan outlining the stages of the commissioning and qualification process, including strategies, responsibilities and timelines.
Design Qualification – DQ):
Verify that the proposed design meets the required requirements and standards.
Installation Qualification – IQ):
Control and verification of the’installation of the equipment and systems, ensuring that they have been installed according to specifications.
Operability (Operational Qualification – OQ):
Testing equipment and systems under operating conditions to ensure they perform as intended and in compliance with quality standards.
Performance Qualification (PQ):
Evaluation of the performance of the’plant under real working conditions to ensure that it meets the expected requirements.
Documentation:
Produce detailed, formal documentation to support each step, including test reports, intervention logs, and compliance.
Troubleshooting:
Identification and resolution of any problems encountered during the commissioning and qualification process.
Staff training:
Training programs to ensure that operators and maintenance personnel are adequately trained on the’use and management of equipment.
Ongoing Maintenance:
Development of guidelines for the maintenance and continuous monitoring of the’system and equipment to ensure that they remain compliant over time.
Audit and verification:
Perform
Importance of C&Q:
The Commissioning & Qualification process is crucial to ensure that plants and equipment operate safely, efficiently and in compliance with regulatory requirements. It reduces the risk of operational issues, improves the quality of the final product, and helps minimize long-term operation and maintenance costs.
Applications:The C&Q it is particularly important in the following areas:
Pharmaceutica
Biotechnology
Feed
Chemical
Water treatment
Implementing an effective Commissioning & Qualification service can therefore ensure the quality and compliance of products and processes, protecting public health and meeting the expectations of customers and regulatory authorities
Areas and facilities we qualify:
Production Equipment – Liquid Formulations and Solid Formulations
Laboratory and Warehouse Equipment
Critical Utilities
Thermal Mapping
Periodic requalification of Systems and Environments
Calibration
Calibration is a fundamental process that ensures the accuracy and reliability of measuring instruments. The following are some of the key features of the calibration service:
Accuracy: Calibration aims to ensure that an instrument measures accurately in accordance with recognized standards.
Traceability: Measurements must be traceable to national or international standards, which means that calibration results must be able to be traced back to recognized measurement references.
Standardization: Use of standardized procedures to ensure consistency and comparability between calibration results.
Documentation: Issue of a calibration certificate attesting to the process carried out, the results obtained and the operating conditions. This document it is fundamental for the quality and compliance of the service.
Technical competence: Operators who perform calibration must possess the specific skills, training and’experience needed to guarantee the service
Types of instruments: The calibration service can cover different types of instruments, including electrical, mechanical, optical and sound instruments, depending on the customer’s needs.
Feedback and support: Offer customer support regarding the use and maintenance practices of the instruments to improve their efficiency and durability.
Consolidated Experience in the Verification and Validation of Clean Rooms
Do you need advice for environmental control or clean room auditing? Scientific Electronics is here to help! With our experience in various industries, we can offer you tailor-made solutions for your every need