Pharmaceutical Client Chooses Modular Evaporation System
Benefits of Package Units
For risk free design of a production plant, many operating companies prefer package units. These turnkey plants are pre-assembled as a black box that can be easily integrated into existing production lines.
By contracting VTA to design and build the entire module, clients experience reduced costs due to decreased time for design and planning, shortened completion times, and total overall capital and engineering costs for time scheduled for commissioning. The project management effort is much easier because of the reduced number of vendor interfaces.
Thin film and short path distillation plants are used for distilling products with high melting temperature, high viscosity or very low operating pressures. Installation of package units is a “risk free” solution that is typical for these types of applications. Thin film and short path distillation plants can be designed as package units up to capacities of more than 20 metric tons per hour. Several units can be combined for even higher throughput.
For supply of a modular evaporation system for a pharmaceutical company producing intermediate products, cooperation between the customer and VTA started with extensive lab and pilot scale tests.
After evaluation of process parameters, process design and planning began. The client’s requirements for available space and internal standards, as well as preferred vendors for equipment, were considered. During each production phase - design, planning, and assembly - the client's preferences and requirements were considered. As a result, smooth integration into the existing plant was accomplished.
Equipment location was clearly arranged and designed for easy access. (This is applicable for all plants, not only GMP applications.)
For production of the specified product, this plant was designed with two thin film evaporators, each in its own module. Pipe connections between the two modules were flanged.
Typical GMP requirements for this plant were specified: polished product wetted surface, aseptic flange connections, FDA approved material, CIP design for product wetted parts and a substantial documentation package for the process and for the plant.
Fabrication in a clean and dry environment
Assembly and fabrication at VTA's manufacturing site allowed all work to be performed inside well arranged areas. As opposed to on-site assembly, the entire manufacturing process took place under clean and dry conditions. Assembly of the two modules was completed within six weeks, including cabling to the switch cabinet and thermal insulation. For transportation via truck, the two modules were separated, and all components supported to avoid damage during shipment. The entire plant was mounted on a rigid steel frame and all components such as pumps and vessels fixed to a rigid structure, reducing special precautions for shipment. The shipment arrived at the client’s site within two days via truck.
The maximum available time available for installation was four days because production on existing plants nearby could not be interrupted for a longer time period. Final assembly on the client’s site required only two days. To install the units, the roof of the building had to be removed and the plant was moved to its final location by a mobile crane. Mechanical testing had already been performed during the assembly phase.
After installation, the plant was connected to existing plant sections as well as to the tank farm for integration into the process. All electrical interfaces were completed and after successful commissioning and production of on-spec product, the plant was accepted by the end user.
Definition of guarantee
Guarantee for capacity, yield, and product quality are the most important requirements from buyer to supplier. The technical basis for guarantees can be theoretical calculations but in most cases is based on the evaluation of pilot test results. Process relevant parameters are checked and documented prior to shipment. During the test run (after commissioning), there is a final opportunity to eliminate discrepancies or minor defects before acceptance by the client.
Process and product guarantees can only be given in case of process design and selection of process relevant equipment by the supplier. For thin film and short path distillation plants, this includes also detailed design of vacuum system, product pumps, instrumentation, and pipe routing as well as plant layout.
Installation of package units is an advantage not only for plants in new facilities but also in expansion of already existing production plants needing increased capacity or improvement of an existing process. When installing a new plant in an existing facility, loss of production during installation must be minimized.
Another advantage of using packaged units is that they can easily be disassembled and moved to another location if required.