Pharmaceutics, Biotechnologies, Healthcare Devices

Comprehensive realisation of buildings and technological units compliant with cGMP and FDA regulations.

We supply complete facilities including structures and technological units for use in the fields of biotechnology and medical engineering that are compliant with EU GMP and FDA regulations. We specialize in the supply of facilities meeting the most demanding requirements of cleanliness (cleanrooms) for work with HPAPI and increased biosafety level (BSL).

Turnkey facilities

Complex services and realization in full: Consultancy and guidance, securing financing, planning activities, development and production, implementation, engineering services, qualification and validation, service.

BLOCK^®clean rooms

Systems for built-in cleanrooms compliant to GMP standards. Our own development and production.

BLOCK^®laboratories

Built-in laboratories, supply of laboratory furnishings, equipment and accessories.

Accompanying facilities

Administrative facilities, storage rooms, restrooms, other necessary facilities.

Heating, ventilation, air-conditioning and refrigeration (HVAC&R)

Heating, air-conditioning and refrigeration including wiring and installation of control systems.

Technological mains/product distribution systems

Clean media as PW, WFI, PS, technological gases and other technological media, process steam, waste management, product distribution mains, CIP-SIP stations and others.

Equipment

Reactors and tanks, filling lines, packaging lines, lyophilizators, tableting machines, homogenizators.

BLOCK^®isolator technology

Individual solutions of isolators and RABS based on a flexible modular system.

BLOCK^®special furnishings

Stainless working, perforated or washing tables, stainless sinks, washing troughs, metal racks, stainless mobile tables and handling cars.

TURNKEY IMPLEMENTATIONS

We complete your projects with turnkey implementation, i.e. a comprehensive realisation of the project from the initial technical design through the execution of all necessary stages from project documentation to implementation, commissioning, measuring, testing, validating, and warranty and post-warranty servicing.

Video presentation of turnkey implementation in the field of Pharmacy: Vaccine Research & Development Center (BNH – Bioveta Novelty Hall).

PLANNING, DESIGN AND IMPLEMENTATION OF CONSTRUCTIONS IN THE FIELDS OF PHARMACEUTICALS, BIOTECHNOLOGY AND PRODUCTION OF MEDICAL TECHNOLOGY

We have long-term experience in following areas:

Production of substances (API, HAPI)
Production of non-sterile medicaments (solid and also liquid forms, liniments, emulsions, sprays, aerosols)
Production of sterile medicaments (injections, emulsions and liniments, aerosols)
Production of radio-pharmaceuticals
Production of medicinal products of modern therapy
Production of medical technology products
Biotechnological production (substances, vaccines)

BLOCK^® SOPHISTICATED AND COMPLEX SOLUTIONS

Emphasis is placed operational safety in every case. We guarantee the parameter stability for even the most demanding processes in research, development, production, control, and distribution of pharmaceuticals. Our supplies and services meet high demands on quality, safety and environmental protection while implementing state-of-the-art approaches to the maximum degree.

Within the BLOCK^® Group we manufacture and deliver our own Forclean^® GMP system designed for the construction of cleanrooms compliant with CGMP and FDA standards where the decisive parameter is the prevention of particle and microbial contamination.

TECHNOLOGY SUPPLIES

Exacting and highly specific demands emerge in the fields of pharmacology and biotechnology. These demands are fulfilled in co-operation with technologists from partnering organizations and companies. BLOCK a.s. designs optimum solutions, the concept of which is the most advantageous from the perspective of requirements on production and operation, construction requirements, operational costs and minimization of environmental impact. Every project is tackled with a maximum level of import laid upon the observance of specified requirements on production parameters. By applying state-of-the-art technical knowledge, we reach significant energy savings in operations and maintenance.

As we deliver technological sets, we observe the philosophy of GEP attitude and guarantee that our projects meet EU GMP and FDA requirements.

ASSOCIATIONS MEMBERSHIP

In order to offer you the best quality services, we support the continuous education and development of our employees and membership in related organizations:

ISPE – THE INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING

Membership for individuals
We work according to Good Engineering Practice and apply the latest knowledge, which we gain through membership in ISPE.
ISPE is a community of pharmaceutical professionals who possesses expert knowledge and create high-quality, cost-effective GMP solutions. ISPE members gain wide and multifaceted advantages that increase their understanding in the pharmaceutical industry, enable them to join similar professionals worldwide and gain abilities to resolve GMP and regulator questions. They are given tools and resources for their professional growth.

www.ispe.org

Swiss Clean Room Concept

The Swiss Clean Room Concept is a community of experts in pharmaceutics in Switzerland.
It is an organization that periodically organizes seminars and training courses on the topic of pharmaceutics in Basel (the heart of pharmaceutics in Switzerland) and put on an “Event” twice a year, to which customers are invited. One aspect this event includes small exhibition tables for the presentation of the suppliers and talks on various topics.

www.swisscleanroomconcept.ch

BLOCK^® REFERENCES – PLANNING, Design and implementation of constructions for pharmaceutical production on a turnkey basis

More references here >>