TSR

TSR - Sterile Reactor

Construction Features

TSR can act as a stand-alone device or can be part of an extended preparation line. The TSR integrates a pneumatic or electric stirring and / or homogenization system, a discharge valve for a complete drainage of the product inside and a thermoregulation system.

Furthermore, the TSR is equipped with all the necessary accessories to make its operation effective, such as load cells to monitor its weight, sprayballs to perform washing and sterilization procedures, safety valves, nitrogen inlet unit, disk of rupture, all the necessary filters with relative housing.

In the executive phase, the Customer has the option of adapting the connections in number and type in accordance with specific needs. The accurate finish, both external and internal, and the preservation of an artisan spirit in the accuracy of its realization makes the TSR TAIM unique in its version.

Machine Directive

The plant is designed, installed, tested and documented according to the Good Manufacturing Practice (cGMP) directive.

Planning, design, including mechanical, electrical and pneumatic construction and instrumentation are carried out according to the specific requests of the Customer, in compliance with the cGMP, EU, FDA directives as well as the current EU regulations such as 2006/42/EC and regulations for low voltage electrical panels.

PED Directive

In compliance with the legislation for pressure equipment the reactor is CE-PED certified (97/23/ EC). The design, carried out by TAIM’d internal technical personnel, will be carried out according to the dictates of the aforementioned EU directive.

At the end of the realization, a hydraulic test is performed and documented at the test pressures required by this standard. The calculations of all the pressure equipment are performed in accordance with the ASME VIII div. 01, or if preferred with VSR calculation codes.

TSR

To meet the needs in the production of sterile and liquid injectable solutions in the pharmaceutical industry, TAIM presents the sterile reactor TSR, designed to guarantee perfect sanitation of the equipment through an automatic cleaning cycle (CIP) followed by a sterilization (SIP).

The sterility of the system does not affect in any way the functionality and safety of the equipment that complies with the PED and ATEX regulations. Sterile reactors can also be used in biotechnological applications, due to the need to carry out accurate sterilization after fermentation processes.

Materials

The materials used for the construction of TSR reactors reflect the TAIM standard for process machines, and will be equipped with appropriate finishes to guarantee the cleaning requirements required for the processes to be performed, ie:

All materials in contact with the product are made of ASME A240 Tp316L stainless steel AISI 316L, or 1.4404, new, free of defects and compatible with pharmaceutical productions
All gaskets in contact with the product are made with elastomers in FDA approved material capable of resisting washing with usual detergents in the pharmaceutical industry
All stainless steel parts not in contact with the product are made of AISI 304, or 1.4301
The visual speculas are made of transparent borosilicate glass, scratch resistant and of appropriate mechanical strength to ensure resistance to internal pressure, of the wire type, without the possibility of product stagnation
All sanitary pipes and interconnections are made of AISI316L stainless steel, ASME BPE
All non-sanitary pipes and utilities are made of AISI304 stainless steel.

Finishes

The finishes with which the TAIM process machines are made can be summarized as follows:

All the parts in contact with the product are made with mirror polished finish, with roughness ra <0.3μm; all the welds are removed, ground flush and then mirror polished until the finish level just described is reached
All external parts have a mirror polished finish, with a roughness of <0.8μm; all the welds are removed, ground flush and then mirror polished to the level of finish just described (also externally) as per the TAIM standard
The gaskets in contact with the product are made with elastomers in FDA approved material, able to withstand washing with usual deter- gents in the pharmaceutical industry
All stainless steel parts not in contact with the product and not in view (such as internal panels, cabinets and casings, have a satin finish Ra <1.6mm.

Automation

The machine is equipped with a power and control panel to collect all the signals present on the machine and process them through an electromechanical logic.

The electrical panel, with IP56 protection, allocates all the electrical units, such as relays, contactors, thermal motor protections and all the components necessary for the correct operation of the system.

From the control panel it is possible to have full control of all the functions of the machine.

The TSR in stand-alone execution can also be equipped with an HMI control panel, with measures suitable for the application.

The software is designed according to FDA CFR 21, part 11 in a simple and intuitive parametric application in line with the GAMP guide, implemented with a SCADA feature that includes process graphics with industrial standards.

The software and hardware for the machine control system are created internally. This translates into a high degree of flexibility for personal needs.

The passages are controlled by sensors. All information is displayed and recorded by the development of the central unit and is made avai- lable each time to the operator.

Teleservice

There is the possibility of installing a proprietary server that allows TAIM technicians to connect to the system at any time with the Customer’s authorization.

The system is always ready for remote assistance through a SIEMENS SCALANCE router that connects to one of the dedicated TAIM Linux 24h servers. It is therefore sufficient to have an Internet connection on the system to be able to intervene in case of need.