Film Coating Machine – Developer
Film Coating Machine – Developer
INTRODUCTION
The tablet coating is the most significant procedure in the pharmaceutical industry, accounting for the last single-unit operation in which the tablets features can be modified. Said modification can be the result of either the application of a color coating, an isolation ensuring the stability of the components during the shelf life, a gastric acids resistant coating avoiding the degradation of acid sensitive actives, or a coating acting as a modulator of the active ingredient release. The coating can also be used as a procedure for the dosage of Active Pharmaceutical Ingredients (APIS) (quantitative coating).
All these possibilities can be effectively achieved only through a system or a film coating machine especially designed, and precisely implemented and customized.
BASIC
The tablet coating is the process of applying a suspension or solution, containing the components needed for the coating formation, on a moving bed of tablets, keeping a constant temperature in the bed. This constant temperature implies a dynamic balance, where the solvent of the applied liquid is at the same time evaporated and eliminated by extraction.
In practice, this balance is achieved by adjusting the following 5 critical variables of the process:
– The applied liquid flow
– The inlet air quality and flow
– The exhaust air flow
– The inlet air temperature and humidity
– The pan speed
CONCEPTION
The REVESTA film coaters are productive process equipments which have been developed through the geometric and functional scaling up from REVESTA
The parameters measured in Galenical scale, can be used to estimate the similarity invariants which allow for the scaling up to REVESTA production.
They are equipped to control each of the critical/ variables that are essential for the dynamic balance: a precise adjustment of the inlet and exhaust air flows Will determine a depression inside the drum. For a given temperature of inlet air, and a flow of suspended application, the core bed in movement Will reach the balance temperature, remaining constant during the whole process.
REVESTA film coaters are equipped with different alarm levels (backup) providing a configuration that offers safety to the operator during a dynamic balanced process as critical as the coating process.
Features
- PLC with color Touch Screen panel.
- Process edition by product.
- Intelligent identification of operators.
- JOG function, for cores heating and cooling.
- Control of differential pressure in filters.
- Solution container.
- Peristaltic pump with volume control.
- Graphics outline.
- PLC condition display on screen.
- Dew point display on screen.
- Printing reports.
- Automatic washing system.
- Remote assistance by IP.
- Electric system according to ATEX rules.
- REAL In Wall design concept.
- According to GMP guidelines.
- FDA - Compliance 21 CFR part 11.
- FAT - SAT - Validation Documents.
