Advanced Reactor Systems for Pharmaceutical Product Preparation
The Customer
A world-leading supplier of softgel encapsulation plants required highly reliable and hygienic reactor systems for the preparation of medicinal products and capsule gels. Considering the strict pharmaceutical industry standards to be adhered to, the client needed a solution that would guarantee precision, consistency, and ease of maintenance without compromising on quality.
The Project
To meet the stringent requirements of pharmaceutical manufacturing, INOXPA provided the client with reactor systems of high quality, designed to offer accurate mixing, precise process control, and ease of use. The emphasis was on developing a system that would facilitate product quality, coupled with ease of maintenance.
Considering the pharmaceutical industry to be a delicate process, particular emphasis was placed on maintaining cleanliness. With the installation of a high-purity water system, all the processes were designed to meet strict quality requirements, making it suitable for medicinal purposes.
Features of the Installation
The installation also includes two 300-liter preparation tanks, each of which is intended for specific purposes.
The first reactor is provided with a counter-rotating anchor, a two-level recirculation system, and a bottom mixer. This arrangement enables effective blending of materials, as well as the distribution of heat. Moreover, a lid-lifting system is incorporated, which facilitates access for inspection purposes, thus enhancing the ease of use of the equipment.
The second reactor is intended for use in the production of soft gel materials. It is provided with an anchor agitator, in combination with a Cowles mixer placed at the bottom. This arrangement guarantees effective blending, which is essential for producing quality materials, particularly in pharmaceutical production.
All reactors and associated plant equipment are supported by a separate service skid. This skid provides vacuum, heating, and cooling using a controlled water circuit. It also provides a CIP (Clean in Place) system, which is used for maintaining hygiene. Such systems are used in water treatment plants as essential water treatment plant components. They make the system more efficient and hygienic.
One of the major advantages of this system is that it is automated. The master control panel is located on the service skid. Each reactor also has its own touchscreen control panel. All these control panels are connected using PROFINET. This makes communication between all parts of the system effortless. This makes it highly efficient, as all aspects of production can be controlled.
The Outcome
The entire system was supplied with a full Installation Qualification (IQ) and Operational Qualification (OQ). This guarantees that all the equipment supplied conforms to all the necessary pharmaceutical compliance criteria and that it is available for immediate operation.
This results in a highly efficient and reliable reactor system that is capable of delivering high-quality output from the very start. With the integration of highly efficient engineering and quality control measures, the solution allows for safe and controlled pharmaceutical manufacturing, fitting for today's manufacturing needs.
FAQs
- What is the role of reactor systems in pharmaceutical manufacturing?
The reactor system is used for mixing and processing medicinal formulations in a controlled environment.
- Why is a high level of hygiene important in these systems?
The level of hygiene in reactor systems is important because the product that is manufactured is medicinal. Therefore, the product needs to be safe and compliant with regulations.
- What is the purpose of IQ and OQ in such projects?
The purpose of performing the Installation Qualification and the Operational Qualification in reactor systems is to ensure that the reactor system is functioning properly and that it is installed correctly.
- How does automation improve reactor performance?
The reactor system benefits in the sense that it can be controlled and synchronized with the help of the automation system.
