Element technology information

Technology for high potency pharmaceutical containment

In the manufacture of pharmaceuticals that possess high pharmacological activity, the containment is a system for shielding the product from the outside, to ensure safe manufacturing operations and ensure the purity of the product. We have technology such as air conditioning as a safety measure against biological or chemical hazards, isolators, and special valves that enable sealed operations.

Case introduction

Photograph: High potency pharmaceutical containment device

High potency pharmaceuticals containment device

What is a high potency pharmaceutical plant?

High potency pharmaceutical plants

Pharmaceuticals that demonstrate high efficacy with small amounts, such as anticancer drugs and immunosuppressants, are in common use. These pharmaceuticals have exceptionally strong pharmacological activity, and there is potential for the substances to exert adverse health effects on operator of the plant, and therefore it is necessary to completely contain such substances. Additionally, high performance containment technology is extremely important from the standpoint of preventing contamination outside the manufacturing facility and adverse impact on other manufacturing equipment within the work site.

Chemical hazard safety equipment

Chemical hazard safety equipment is installed in high potency pharmaceutical plant that to prevent the exposure of high potency pharmaceuticals. The systems ensure safety through the use of primary isolation equipment (high potency pharmaceutical containment equipment and air line suits) for preventing adverse health effects on operator, as well as with secondary isolation equipment that prevents leakage of high potency pharmaceuticals to the exterior by using negative pressure control and HEPA filters.

Scope of supply

In relation to high potency pharmaceutical plants, we offer chemical hazard safety equipment as well as comprehensive solutions that include equipment with engineering of high potency pharmaceutical plants (from basic design to detailed design), validation, procurement, installation, and commissioning with our high potency pharmaceutical containment equipment as the core technology. This enables support for a full range of high potency pharmaceutical production processes, including pharmaceutical plant, chemical synthesis pharmaceutical plant and drag formulation plant.

Fields of application

This equipment is suited to customers in the pharmaceuticals production business.

Customers planning high potency pharmaceutical plant.
Customers that want to raise the cleanliness of areas that have potential for exposure by raw materials, intermediate substances, and products during the process.

The production process can be for either biopharmaceutical plant, chemical synthesis pharmaceutical plant or drag formulation plant.

Technology

High potency pharmaceutical equipment for Containment

Photograph: Isolators for equipment isolation
Isolators for equipment isolation

High potency pharmaceutical containment equipment

Application

These prevent exposure by pharmaceuticals possessing high potency, and they ensure safety for operator of the plant.
These ensure the purity of processes (raw material supply, intermediate substances, product discharge, seed crystal supply, sampling etc.) that are exposed to the surrounding environment.

Features

It is possible to execute sealed and automation processes that handle powders (raw material supply, intermediate substances, product discharge, seed crystal supply, sampling etc.).
Containment of high potency pharmaceuticals is achieved through isolation of restricted parts.
Internal cleaning is easy, and exposed powders can be disposed of safely.
We provide primary and secondary physical containment with chemical hazard safety air conditioning and air line suits.

Element technology, device overview

Docking systems: These are systems for automatically connecting powder supply and discharge.
Active and passive valves: These are valves used in the above connections. Air is removed by a special mechanism to enable smooth operations.
Sealed sampling devices: These perform sampling in a sealed state.
Isolators: These partially isolate processes that handle powders, in order to increase safety. These have good operability and superior economy.

(in-house comparison)

Introduction to research laboratory

We engage in research and development of pharmaceuticals technology at the Energy and Environment Research Laboratory. This research laboratory develops hardware and software for fermenter and biological processes. Biological systems are verified by focusing scientific investigation on the optimization and increased efficiency of fermenters. A 200L cell culture jar is in place and is capable of actual culturing tests. When scientific evidence is required for validation, we support the customer and the project teams at the research facilities.

Hitachi, Ltd., Energy and Environment Research Laboratory
Postal Code 319-1221 7-2-1 Ohmika-cho, Hitachi City, Ibaraki Prefecture,