What can the customer find in a spare parts list?
For FPS it is important to facilitate as much as possible the proper selection of the part to be substituted in case of equipment maintenance or malfunctioning. For this reason, in the spare parts section of the Use and Maintenance Manual, the customer will find:
What does a complete spares package include?
FPS core business is containment systems. We also have our own line of Milling & Micronization systems. For each type of systems we will draft a customized spare parts list.
Spare parts for containment system
Containment systems are designed and manufactured for either the production and handling of highly potent API or for sterile products. For highly potent APIs what is really important is to separate internal environment from the external with the aim of protect the operators. A negative pressure regime and a turbulent airflow are adopted as further means of protection. For sterile products the goal is the opposite.
The technician operates in the chamber through gloves. These can be in different materials and sizes depending on the customer requirements. They are fixed to gloves flanges with O-rings, usually two units for each glove to assure extra safety.
In containment systems gaskets play an important role because they guarantee the tightness of the chamber and, consequently, help keeping the pressure constant. Depending on the application and the design of the isolator, seals can be inflatable or static, mainly in silicone or EPDM material, and are installed on each port that communicates with the external environment or that separates chambers.
Each working chamber is always fitted with HEPA filters, positioned on inlet and outlet lines; these items can be ‘push-push’ or ‘screwed’ type. Filters can be also be changed from the inside of the isolator to assure requested containment.
The washing system is composed by a spray-gun linked to a spiral flexible pipe which permits to reach every part of the chamber and clean it easily.
To introduce and take out products or tools from the working chamber, a bag-in/bag-out port and a liner can be present on equipment structure. Continuous liner bags can be supplied in different sizes together with O-rings, that assure a proper positioning of the bag. To seal continuous liner, there are two main options: using a welding machine or, as an alternative, fixing the bag with crimps.
Containment can be applied also to sterile field: in this case, it is important to isolate and protect the product inside the chamber from the operator. For this reason, a positive pressure regime is adopted, together with a turbulent or unidirectional airflow.
Concerning spares, in addition to those listed above for toxic containment, it is important to consider items involved in the decontamination process with H2O2 (Hydrogen peroxide).
For all systems, in both fields mentioned, FPS team emphasizes the importance of planning a regular maintenance. Our aftersales department is always available to discuss the matter.
To explore the theme, please click here, where Rita Masiello, Service and After Sales Manager, talks about the importance of scheduled maintenance and after sales service.
Click here to access the offer dedicated to spare parts!
Contact our team and define together your custom spare parts kit: sales@fps-pharma.com
