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Industrial plant : Hitachi

Hitachi

Aseptic and clean technology is indispensable for maintaining the safety and quality of pharmaceutical products. We take a comprehensive approach in engineering and installing pharmaceuticals equipment, with the purpose of preventing bacterial contamination through the use of sterilization, eliminating residues by the cleaning of equipment, and averting outside foreign object inclusion, as well as preventing cross-contamination between products produced on the same equipment by clean air conditioning. Our wealth of experience in engineering and constructing pharmaceutical plants contributes to high quality pharmaceuticals manufacturing.

(in-house comparison)

Case Introduction

[Biopharmaceutical plant that incorporates the SIP and CIP systems]

Photograph: Biopharmaceutical equipment that incorporates the SIP and CIP systems

This is an example of our delivery of domestic top level cell culture pharmaceutical plant.

Verification of cleaning effect

Affiliated with Hitachi group research laboratories

We have accumulated cleaning effect and design data for target cleaning items (equipment, piping) by coordinating with many Hitachi group laboratories with the Hitachi, Ltd. Energy and Environmental Systems Research Laboratory.
This data is used for engineering actual plants, and it is contributing to the manufacture and construction of pharmaceutical plants having high product quality and safety.
This is an example of research results related to cleaning performance for culturing.

(in-house comparison)

Scope of supply

We provide comprehensive support, from engineering, through manufacture, procurement, construction, to validation.

SIP (Sterilization In Place)

SIP support for sterilization equipment such as boilers, pure steam generators, sterilization filters, and automatic control and monitor equipment

CIP (Cleaning In Place)

CIP drive and cleaning fluid supply system, rinse water manufacturing and supply system (pure manufacturing water, water for injection), automatic control and monitor equipment
CIP support for cleaning equipment

Clean air conditioning

Clean rooms (including biological clean rooms, negative pressure control chambers), sterilization chambers, isolators

Fields of application

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

  • This is for customers with plans for Biopharmaceutical plant, Chemical synthesis pharmaceutical plant or drug formulation plant.
  • This is for customers with plans for pharmaceutical intermediate substances plants.
  • This is for customers who will upgrade their existing plant to bulk pharmaceutical GMP compliant plant.
    We deliver clean air conditioning and cleaning systems.
  • This is for customers who will upgrade their non-aseptic pharmaceuticals to aseptic bulk pharmaceuticals.

Technology

SIP

We sterilize equipment by steam sterilization without disassembling them. When steam generates a thermal denaturation problem for raw materials and pharmaceuticals, we perform sterilization filtering. These operations are executed with a fully automatic program.

SIP validation
We verify whether or not the equipment has reached and maintained the sterilization temperature needed to obtain complete sterilization. We execute integrity tests for disinfection filters.
  • * We support the sterilization test being operated by customer.

CIP

We eliminate foreign objects and residuals within the equipment, without disassembling them.
With the cleaning solution drive system utilizing ejectors, it is possible to recycle the cleaning solution, which results in economical cleaning.
The series of cleaning operations are fully automatic.

Cleanig validation
We verify the cleaning operation.
We rinse after cleaning with caustic soda, and then we check for any residual caustic soda.

(in-house comparison)