Frewitt’s redesign of the MF-Line has paid off. At least, this is the opinion of Remedica, a pharmaceutical company from Cyprus, which uses the Oscillowitt to mill heat-sensitive solids. The redesigned sieve mill produces a narrow particle size distribution with only a small number of fines. Furthermore, it has an elegantly simple design with fewer components and can be integrated into almost any facility at comparatively little expense.
Author Roy Housh Director of Sales, Frewitt
Frewitt first presented the Oscillowitt to a specialised audience at Powtech 2013 after completing a substantial redesign. Compared to the mills in the MF-Line, which have been firmly established in the pharmaceutical market for decades, the Oscillowitt features the following design differences:
- Improved ergonomics of the milling head and the drive while maintaining the tried and validated milling chamber geometry
- Rotor angle shifted by 2° after each pendulum motion to ensure all rotors are equally used
- Easy wall mounting for cleanroom applications
- Rotor speed indicated on an LC display
- Pressure resistant design in response to increased Atex requirements
- Variable oscillation angle permits a higher throughput
A customer who has been working with Frewitt for many years was among the visitors to Powtech 2013. Remedica, a company based in Cyprus, manufactures generic medicines in several different forms: tablets, capsules, suppositories, syrups, etc. Like all generics manufacturers, Remedica operates in a market which current pharmaceutical market studies predict will grow very fast in the next few years. According to one such study, published during Interpack 2014, pharmaceutical manufacturers will succeed in meeting this growing demand “if the machines provide better performance and production becomes more flexible. Overall equipment effectiveness, or OEE, must be used to modernise and optimise existing facilities” (from an article in “2014 E-Convention/Interpack”).
The desire to improve the OEE of their machines was the reason why Remedica staff visited Frewitt at Powtech. On the one hand, Remedica wanted to continue reaping the known benefits of the oscillating milling machines in the MF-Line; on the other, they were also looking for a milling system that would meet the new requirements (higher productivity, greater flexibility for manufacturing a larger number of products).
It was clear to Remedica from the outset that the oscillating mill should serve as a starting point because its operators were already very familiar with the machine’s functions; the customer was not keen to pay for additional training and revalidation, and desired to retain the MF-Line process in the Oscillowitt as far as possible. Based on their experience with the MF-Line and the above-mentioned arguments, Remedica assumed that the planning and implementation costs would be much lower if they migrated to the Oscillowitt than if a machine built with another technology were to be introduced. They would also have the benefit of being able to conduct realistic in-house trials and analyse the products in their own laboratory as a precondition of reliable results throughout the production process.
Implementation according to plan
All in all, three projects were implemented:
- Two mills for the API area
- Three mills with stepless height adjustment and a filling system for various containers
- Three mills with a filling system for various containers
Remedica wanted to use only one Oscillowitt model in order to minimise the costs for maintenance and the number of spare parts. Empirical experience and product tests soon showed that the Oscillowitt-6 met all the requirements for the three projects unconditionally, making it the perfect choice. Project 1 consisted of a mobile machine with a high frame (1700 mm) and a DN 300 inlet as per ISO 2852 which could be docked to a container for 800 x 800 or 1000 x 1000 mm.
The systems for project 2 and 3 were identical. The mobile machines had to be designed with the standard height. The inlet had to consist of a conical funnel with a diameter of 315 mm, a special connector and a DN 300 outlet with a ProFi-Lun connector (bag holder).
In total, eight Oscillowitt-6 sieve milling machines were manufactured on time and subjected to a FAT test, which only required two days. The mills now installed at Remedica can operate at containment level 5 and are WIP-capable; they comply with all relevant regulations during the cleaning process thanks to their cavity-free design.
Like the MF-Line, the Oscillowitt mainly mills heat-sensitive products; the process is particularly gentle due to the low rotor speed and the product is only heated to a minimal degree in the milling chamber. Milling the product in its ambient state means that the contents (in Remedica’s case, the molecules of the active ingredients) remain unchanged. Frewitt’s engineering team has achieved the gentle milling process the customer was seeking through design changes while at the same time increasing the throughput by 15 % compared to the old MF-Line.
Hall 1, Booth 442