Telstar has released a new single-vessel good manufacturing practice (GMP) production freeze-dryer that is optimised...
Telstar have completed the construction and installation of a modular research and development laboratory, and kilo lab at the Medichem production centre in Hal Far, Malta.
It is designed for manufacturing highly potent active pharmaceutical ingredients (HPAPI). The facility includes a production room and a laboratory, which is under negative pressure relative to adjacent rooms and the exterior, ensuring user protection.
Telstar carried out the project management of the facility under an engineering, procurement and construction (EPC) arrangement. The architecture, heating, ventilation and air conditioning (HVAC) system, distribution of utilities and services, provision of heating and cooling water, and interior furnishings were included in the project.
Telstar undertook the detail and construction engineering phases, relying on direct client involvement and purchasing of materials. Continuous supervision of material quality and workmanship was necessary to achieve approval and validation of the facility.
The modular laboratory was built as a single structure, comprising of nine rooms grouped in four areas. These four areas consist of: a production area, including two 15l reactors, a filter dryer and a micronizer; a research and development laboratory, a technical area and staff changing rooms.
The technical area is designed for the air handling unit, hydraulic installation, electrical and control cabinets, and a vacuum system. Telstar’s design and construction for the facility produced HPAPI’s in a good manufacturing practice (GMP) environment, with containment levels of 40ng/m3.
A modular approach enabled the entire system to be assembled and qualified in the Telstar manufacturing facility in Estonia. From an operational standpoint, there were advantages in terms of availability, control and access to construction materials and manpower, without relying on the supply capacity in the client country.
It also resulted in considerable cost-savings, as staff spent less time travelling and due to reduced implementation time on-site.
The modular facility was installed, commissioned and validated in its final location at the Medichem premises in Malta within one month. With conventional construction techniques, it would have taken six months to complete the project on the client’s premises. A modular design structure enabled Medichem to easily modify the facility and relocate it, if required in the future.
High containment and maximum safety
The modular laboratory developed for Medichem fulfils the high containment and maximum safety specifications required when operators handle highly active ingredients.
For example, air extraction from the rooms utilizes Bag-In/Bag-Out (BIBO) safe change filters, to eliminate the risk of cross-contamination and protect the operator during filter changes.
An emergency shower has been provided at the exit, which the operator can use in the event of a hazardous spill. In addition, the Kilolab ATEX 3G classification for all the equipment in the room including switches, push buttons, light fixtures, and power outlets, protects against explosions that are a risk when flammable solvents are being processed.
Telstar has also included an innovative system for distributing breathable air. Breathable air connection points have been installed in all rooms in the event of an emergency, which means the operator has access to a safe supply of air stored in cylinders installed outside the module.
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