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LABORIALSTERILE by LABORIAL
Laborial Sterile is a solution of Laborial group, developed in order to address a specific market segment, focusing on providing targeted solutions for handling cytotoxic and sterile liquids. This project results from the experience and knowledge acquired over the years, carried out by an experienced and specialized technical team at different levels of expertise, from design and implementation to monitoring and inspection work, as well as team empowerment, ensuring the accomplishment of such projects according to the most demanding international standards and norms.
Laborial Seterile proposal is therefore based on an integrated solution of specialized engineering, technical furniture and equipment installation and the development of intelligent technological products specifically for sterile areas, but also for other controlled environments, providing a significant optimization of processes and resources.
Laborial worldwide
REQUIREMENTS
Building a laboratory for sterile drugs, preparation for parenteral nutrition, cytotoxic drugs and other medicines.
Analysis of operational requirements in function of the different works and different spaces in accordance with the ISO 14644 standards, GMPs and other guidelines and regulations.
Specialized training with certified technicians on specific entitities that includes theoretical and on-job learning, for professionals that will use these spaces.
Effective maintenance plan to keep the facilities in accordance with quality and safety principles, and optimiziation of exisiting conditions and quality procedures for the certification by external entitites.
Ensure safety in operation and administration of cytotoxic, parenteral nutrition and other sterile products.
Facilities and support infrastructures that adapt to an existing building, a new building or to emergency situations in areas without buildings and lack of infrastructures.
MAIN SPECIFICATIONS
The functional organization of a controlled space is based, among others, in the proper partitioning of rooms with different requirements in order to ensure product, operator and environment protection.
The requirements and classification of this kind of spaces are developed depending on the work that is going to be done on them.
The selection of suitable materials is critical to achive the best performance in the controlled space.
The selected materials promote asepsis of the critical areas either by the reduced accumulation of particles aswell for the easy cleaning and disinfection.
The ventilation system for controlled areas is extremely important to ensure product, operator and environment protection.
The air flow rate and spaces air removal are conceived according to the space requirements but also as a second protective barrier.
The difference in pressure between different sorting areas is essential to minimize contamination between spaces.
The infrastructures are developed according to the customer's requirements / process but always serving an integration that promotes asepsis.
For controlled spaces is always recommended sealed and with smooth edges accessories.
The furniture and equipment for controlled environments is designed for seamless integration with the space and allowing flexibility, functionality, aesthetics and and an easy maintenance.
We respond to the asseptic requirements using non-porous surfaces material that allow an easy cleaning and disinfection.
Compliance with the requirements is always conducted by independent entities in accordance with the applicable regulations.
CONCEPT
INLINING AND CONSTRUCTION MATERIALS
AIR TREATMENT AND PRESSURE DIFFERENTIALS
INFRASTRUCTURES
ASSEPTIC FURNITURE AND ACESSORIES
TESTS AND VALIDATIONS
Diagnostic
Risk analysis
Data and statistics analysis
Identification of space requirements
Aseptic class Identification
Supply and
installation
Project execution
Procurement and Logistics
Managing and supervision
HST coordination
Control and testing
Technical
assistance
Tele-Pharmacy
Preventive maintenance
Supply and supplies management
Specialized technical support
After-sales service
Conception
Conceptual definition
Legislation and rules study
Requirements for space accreditation
Process optimization
Global resources evaluation
Comissioning
Built plans and specifications
Inspection reports and tests
Instruction manuals
Instalation validation and qualification
Maintenance plan
Specialized
Engineering
Mechanical and electric installation
Hydraulic, gases and utilities installation
Technical furniture and equipments installation
Centralized technical management
Wast management
Training
Specialized training with certified technicians on specific entities
On-Job training
Development of laboratory procedures
Implementation of quality control system
PROJECT STAGES
INTEGRATED GLOBAL SOLUTION
REFERENCE PROJECTS
OTHER CONTROLLED ENVIRONMENTS
WASTE MANAGEMENT
Waste management plan
Incineration or other treatments
Waste sorting and packaging
ANTEROOM
Transition areas between different asseptic classes
Gowning procedures to access handling room
SUPPORT ROOM
Drugs and reagents storage
Instruments storage
Supply for handling rooms by transfer hatches
Administrative procedures
HANDLING ROOM
Proper level of assepsis
Input and output materials via transfer hatches
Access of people from the anteroom
DRUG ADMINISTRATION
Patients screening
Drug administration areas
Pharmaceutical products procurement
Supporting material
Patients administration records
SUPPORT MODULES
Additional modules for:
+ water
+ gas
+ electricity
PRODUCTS
TECHNOLOGIC
+
EQUIPMENTS
CLEANING
FURNITURE
CONSUMABLES
Segregation concept for Laborial's cytotoxic integrated global solution, that meets the most demanding requirements in this type of laboratories.
CONTACTS
LABORIAL STERILE
LABORIAL, SOLUÇÕES PARA LABORATÓRIOS
Via Francisco Sá Carneiro - Rua A, 91
Zona Industrial Maia I, Sector VIII
4475-132 Maia • Portugal
Tel.: +351 962 023 353
Tlf.: +351 219 598 163
www.laborialsterile.com
www.laborial.com