STERIGENE, a major supplier in the field of ultra-cleanliness and an expert in project management, has joined the SYNEXIN group since the beginning of 2022. Through the fusion of process knowledge and experience in project management for the pharmaceutical industry of its entities, SYNEXIN is able to support you in carrying out your project.
SYNEXIN brings together several entities competent in clean and sterile processes, in aeraulic expertise, in the design and layout of critical areas as well as in clean room consumables. It is not just a matter of offering the equipment, furniture or consumables you need for your project, but of supporting you during its implementation with overall management: from implementation to finalization through qualification. of your equipment or your critical environments via dedicated technical monitoring.
SYNEXIN is a company that brings together several entities, all specialized in different professions linked to critical environments.
The single point of contact for the engineering of your clean and sterile processes: process equipment, technical services, consumables and personnel equipment.
The specialist in the field of controlled environments: equipment and components for aeraulic systems, qualification of critical environments.
The expert in the integration and manufacturing of tailor-made furniture for clean rooms: viewing tables, passage benches, furniture, consumable dispensers and changing rooms.
With this knowledge and skills, SYNEXIN is able to propose and establish a validation strategy for your project based on process risk analyzes as well as the design qualifications of your projects.
OUR METHOD
RISK ANALYSIS
Process risk analysis is an essential step in project management. It is :
- Carry out a risk inventory for all stakeholders (maintenance, operators, metrology)
- Value risks with a risk rating according to severity calculated from occurrence, frequency and detectability
- Define appropriate solutions and tests according to the risk rating in order to reduce their occurrence.
All these steps aim to identify the critical elements which will necessarily be integrated into the qualifications. We therefore offer you a file including:
- A summary of each function of your system
- A summary of the risks associated with each function
- Identification of the causes and consequences of each risk as well as their criticality
- Possible means of controlling risks
- Developing the validation strategy via defining validation tests
This file is established according to the regulatory standards below.
| REFERENCE | TITLE/SOURCE |
| GMP revised on 11/26/2020 | Good Manufacturing Practices |
| EU GMP – Annex 1 08/22/2022 | Manufacturing of sterile medicines |
| GMP – Annex 11 | Computerized systems |
| GMP – Annex 15 | Qualification and Validation |
| ISO 9001 rev 2015 | Standard for Quality Management Systems |
| ICH Q9 | Harmonized Tripartite Guideline “Quality Risk management” |
| ISPE Baseline guide Vol5 | ISPE baseline Pharmaceutical Engineering Guide for New and Renovated Facilities, Vol5 “Commissioning and Qualification” |
| ISPE Baseline Guide Vol12 (Gamp 5) | Science and Risk Based Approach for the Delivery of Facilities, Systems and Equipment |
