Site Basic design – BİOİNNOVATİON BİYOMÜHENDİSLİK DANIŞMANLIK

Home
About Us
Products
Our services
- Project Servıces
  - Site Basic design
  - Detail Engineering
Consultancy Services
- Consultancy Services
- Documentatıon Consultancy
Contacth

Home
About Us
Products
Our services
- Project Servıces
  - Site Basic design
  - Detail Engineering
Consultancy Services
- Consultancy Services
- Documentatıon Consultancy
Contacth

Site Basic design

Process Definition

In according to customer requirements, production
steps of medicinal products, primarily vaccines
and biotechnological products, are defined in
compliance with cGMP rules.

Determination of Process Equipment and Preparation of URS

The main equipment to be used in production
and quality control activities are determined
according to the capacity calculations and the User
Requirements Specification (URS) is prepared in
accordance with the cGMP rules.

Draft Project Design

The first and most important step of the
manufacturing is the concept design in the medical
product industry that is compatible with cGMP rules
with low installation and operating costs, short
commissioning time, high capacity and low cost
production. All engineering projects, equipment and
processes, validation and maintenance activities are
built on concept design.

Biosafety Project

When designing a GMP manufacturing facility for
biological/immunological products, there should
be huge experience and detailed risk assessments.
For such projects, the rational and optimal solutions
are offered for the architecture, equipment, HVAC
system, clean utilities (water, steam, etc.) and
effluent management that meet the requirements
of the cGMP and WHO biosafety (BSL-2, BSL-3,
BSL-3+, BSL-4) guidelines.

HVAC Principle Sheme Design

Clean room zone plans, HVAC zone plans, biosafety
zones and special solutions for hazardous
products are the rooms/areas that form the basis
of detail (calculation) engineering projects.

Preparation of Principle Schemes For The Pharmaceutical Water and Steam Systems

These are the projects where pharmaceutical
water and steam systems to be used in production,
which form the basis of detailed engineering
(calcualtions) projects, are separated in terms of
cGMP and biosafety rules.