Turnkey solutions

In order to meet the constant evolution and development of drugs and their routes of administration, KEYPACK is based on a modular design concept that is highly flexible and adaptable. Depending on the requirements a full range of top-of-the-line configurations with complete options is available, as well as simpler layout solutions.

Protection technology

Aseptic pharmaceutical production requires that the production area be free of microbiological and particulate contamination.

Environmental conditions for aseptic processes are designed to maintain product sterility and achieve ISO 5 or Class A classification, and the following parameters should be considered:

—— Particle levels (> 0.5 micron) are less than 3,520 particles per cubic metre.

KEYPACK is available in a number of different barriers to meet customer needs:

LAF - Laminar Flow

It is a dynamic barrier provided by a laminar airflow filtered through a high efficiency filter (HEPA) that removes particles from the filling/sealing area.

ORABS - Open Restricted Access Barrier System

In addition to the dynamic barrier provided by the laminar airflow (LAF) filtered by a high efficiency filter (HEPA), it also includes physical barriers between the operator and the product, such as: glass guarded doors, gloves, quick transfer ports etc. Air is drawn in from the room where the equipment is operating and exhausted directly into the room.

CRABS - Closed Access Restriction Barrier System

Physical and airtight barrier between operator and product. Air is recirculated through a dedicated return air duct inside the airtight chamber.

The system allows to work with differential pressure (positive/negative) to the surroundings and to monitor and control the process parameters (air velocity, differential pressure, temperature, relative humidity...). etc.).