Cassettes are doubly packaged in outer boxes of 60 units, gamma sterilized and supplied with full documentation of conformance to specification. Logistics are smooth and simple, and shipments can be combined with O-18 water, FDG precursors and/or accessory packages.
Finally, a full range of accessory packages - filters, cartridges, syringes, etc. - for FDG synthesis are readily available.
Rotem also supplies additional disposable assemblies on an OEM basis for other modules employed in nuclear medicine.
The “Plastic Cassette for TRACERlab MXFDG Synthesizer” (Rotem catalog number PC50) is a disposable assembly for use with the TRACERlab MXFDG module.
The assembly of the cassettes takes place in a dedicated room in the Class 8 (100,000) clean rooms at the Rotem site in Rotem Industrial Park. This facility is regularly tested for presence of particles and sterility and found to meet the requirements for production of active pharmaceutical ingredients.
The production staff is specially trained for cassette assembly with an emphasis on adherence to work instructions, maintenance of the aseptic atmosphere and the utmost attention to issues of quality. It should be noted that the assembly staff is concerned only with this subject and does not engage in other work for Rotem.
- The production process is based on weekly lots of 240-720 units.
- Components, which are supplied in double packaging, are introduced to the clean room according to the relevant procedure. The correct number of each component is removed from the outer packaging, counted and placed in plastic bins for the relevant lot.
- Assembly is carried out according to the work instructions. Each manifold is assembled separately, the cap is fixed to the reactor vial and the final cassette is connected.
- After verification that all the counted components have been used, the connected cassettes are inserted into plastic sterilization pouches and heat sealed. The product label, showing production lot number and date, is printed and both it and the sterilization indicator are affixed to the pouch.
- The cassettes, in their pouches, are placed in a labeled, laminated white carton that contains 60 cassettes. Two such cartons are inserted into a labeled outer brown shipping carton. (Samples of all labels are attached.)
- The cartons are sent to a U.S. FDA-inspected supplier of gamma irradiation sterilization services (Sor-Van Radiation Ltd.). They are sterilized according to the specification agreed upon with Rotem, minimum 2.5 Mrad and returned to Rotem within five days of receipt.
- Following QC clearance the product is released for shipment to clients.
All aspects of the cassette assembly process, including facility operation and maintenance, incoming material procedures, the actual assembly, sampling and quality assurance, are defined in a set of Standard Operating Procedures.
All components are supplied by approved suppliers. Technical specifications are clearly defined and parts are supplied with a certificate of conformance. On receipt of parts, they are subject to an acceptance test before being logged into inventory.
The entire production process is documented in a “batch record” coinciding with normal cGMP procedures. This record ensures full traceability of the components used, process steps, personnel, terminal sterilisation and testing results pertaining to the lot.
During the assembly process there are several points at which components are counted to ensure that none has been omitted. The final cassette and pouch are visually inspected in a distinct step.
Following gamma irradiation and verification that the indicators changed color from yellow to red, two cassettes from each production lot are used to produce FDG on a TRACERlab MXFDG module. The test protocol requires passing of the pre-synthesis pressure/vacuum test and achieving acceptable yield in the final FDG production.
A Certificate of Conformance (see sample attached) accompanies each shipment.
All production and quality records as well as a sample from each lot are retained for a minimum of five years from product release.
The process is open to quality audits by Rotem clients.
Production and quality assurance procedures are well defined in SOP’s that are regularly updated. Full traceability is maintained through the use of clear identification of each cassette and correspondence to the relevant batch record. Samples of each lot are tested in production conditions similar to those used by the actual users prior to release for shipment.
This is to certify that
- The above mentioned product meets the requirements of Rotem specification PC1L3, which conforms to the “Hardware kit” as defined by the original supplier of the Coincidence FDG Synthesizer.
- Performance of this product has been validated in accordance with applicable Rotem procedures.
- Assembly was carried out in a clean room.
- The final product was sterilized by exposure to 2.5 Mrad (25 kGy) minimum gamma irradiation.
Amos Freud, Ph.D
Quality Assurance Manager
4 Jan. 2009
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