In the production of pharmaceutical oral solid preparations (tablets, pills), film coating is a key process for improving drug stability, masking odors, and achieving enteric/sustained-release function. Traditional equipment often faces problems such as uneven coating, slow drying, and excessive solvent residue, making it difficult to adapt to the demands of refined production. The film coating machine launched by Taizhou Tiantai Pharmaceutical, with "precise temperature control, uniform coating, high efficiency and compliance" as its core, has become the preferred equipment for the coating process of pharmaceutical enterprises.
1、 Structural Design: Targeting the Core Pain Points of Pharmaceutical Coating
Equipment is optimized from three aspects around "uniform film formation" and "clean production":
•Multi dimensional material movement system: adopting the design of "tilted pot body+flexible guide plate", the tilt angle of the pot body can be adjusted from 15 ° to 30 °, and the speed is 30-60rpm, ensuring that the material "rolls suspended" without accumulation; The guide plate reduces collision wear, and the fragment rate is controlled below 0.5% to ensure the appearance of the formulation.
•Efficient Atomization Spray System: Equipped with 2-4 dual fluid atomization spray guns, with a spray volume of 50-500mL/h and independently adjustable atomization pressure, the coating liquid is atomized into 5-10 μ m droplets; The spray gun is 360 ° adjustable in direction, with a coating uniformity of 98%, avoiding local thickening or missed spraying.
•Fully enclosed clean chamber: The parts in contact with the material are made of 316L stainless steel, with almost no mirror polishing (Ra ≤ 0.4 μ m)dead angleNegative pressure exhaust+efficient filtration to prevent solvent leakage, double-layer glass observation window (with lighting) for real-time monitoring, in compliance with GMP cleanliness requirements.
2、 Core advantage: Balancing quality and efficiency
•Precise temperature control+gradient drying: "Hot air circulation+zone temperature control" system, inlet air temperature of 40 ℃ -80 ℃ (temperature difference ± 1 ℃), supports gradient heating (such as 45 ℃ → 60 ℃ → 50 ℃), avoids material discoloration, film cracking, and residual solvent content ≤ 0.5%.
•Efficient and energy-saving: The waste heat recovery device can use 30% of the exhaust heat to preheat the fresh air; The design of "lower air inlet+upper air outlet" improves heat transfer efficiency and shortens drying time by 20% -30% compared to traditional equipment. It only takes 2-4 hours to coat a single batch of 100000 tablets.
•Intelligent compliance: PLC touch screen can preset and store more than 50 sets of formulas, with one click calling to reduce errors; Real time recording of temperature, pressure and other data, supporting export traceability; Provide verification documents for key components to meet IQ/OQ/PQ and FDA/EMA standards.
3、 Pharmaceutical exclusive application scenarios
•Ordinary tablets: used as gastric soluble coatings for antipyretic and analgesic tablets and vitamin tablets to mask odors, enhance stability and gloss.
•Enteric coated preparations: Suitable for aspirin enteric coated tablets and omeprazole enteric coated microspheres, ensuring that the coating film is resistant to gastric acid and intestinal disintegration.
•Sustained release/controlled release formulations: Control the thickness of the coating film of nifedipine sustained-release tablets to achieve slow drug release and prolong the efficacy.
4、 Full cycle service guarantee
Tiantai Pharmaceutical provides customized solutions (with a pot capacity of 50L-500L optional), on-site installation, debugging, and process training, assists in writing GMP validation documents, conducts regular inspections and maintenance, and reduces enterprise operation and maintenance costs.
As the core equipment of pharmaceutical coating, this film coating machine helps enterprises improve product quality with "uniformity, precision, and efficiency", and promotes the standardization and upgrading of oral solid dosage form coating technology.