Hot melt Granulation and Coating

• Moisture or heat sensitivity: APIs or excipients that are sensitive to moisture or high temperatures, can benefit from hot melt coatings since the process does not involve water or other solvents, neither high temperature in the fluid bed.
• Uniform Coating: Hot melt coatings provide a uniform and consistent layer, which can be critical for ensuring dose uniformity and the controlled release profile of the drug.
• Process Control: Precise control of temperature and other process parameters is essential to ensure consistent coating quality and performance.
• Controlled release: In pharmaceuticals, hot melt coatings can be formulated for controlled release, allowing the medication to be released gradually over time. This improves drug delivery and patient outcomes.
• Beeswax: is a highly effective excipient for hot melt coating in the pharmaceutical industry, especially in fluid bed systems. Its natural, biocompatible properties, combined with its excellent barrier and film-forming abilities, make it ideal for controlled release, taste masking, and moisture protection applications.
• Energy efficient: Together with the Ventilus USP process times are significantly reduced compared to other Fluid Bed on the market. In addition to this, there is no need to heat up the inlet air at higher temperatures as heat loss it is been recuperated. 

How does hot melt coating help reduce production costs?

Hot melt coating offers several advantages that contribute to reduced production costs:
Faster Processing: Compared to traditional solvent-based coating, hot melt coating boasts significantly faster processing times. This translates to increased throughput and reduced equipment utilization costs.
Reduced Waste: The efficient and targeted nature of hot melt coating minimizes material waste. Additionally, the elimination of solvents eliminates solvent disposal costs.
Lower Energy Consumption: Hot melt coatings require lower inlet air temperatures compared to solvent-based coatings and significantly shorter processing times, resulting in lower energy consumption.

What is the life expectancy of Romaco’s hot melt coating equipment, and what maintenance is required?

Romaco equipment is known for its durability and reliability. Regular inspections and cleaning are recommended to maintain optimal performance and ensure long-term equipment life.

How does Romaco ensure regulatory compliance with cGMP and FDA standards?

Romaco prioritizes regulatory compliance. Their hot melt coating systems are designed and manufactured according to cGMP and FDA guidelines. Additionally, they offer comprehensive documentation and validation support to help pharmaceutical manufacturers meet regulatory requirements.

How does Romaco’s hot melt technology handle temperature- and moisture-sensitive APIs during the coating process?

Romaco's hot melt coating technology addresses the challenge of handling moisture-sensitive APIs by offering a solvent-free process.   
Minimal Moisture Exposure: Unlike solvent-based coating methods that often transmit humidity into the API while drying, hot melt coating utilizes heat to melt the coating material. This minimizes the exposure of the API to excessive humidity, reducing the risk of degradation or loss of potency.   
Precise Temperature Control: Romaco's equipment incorporates precise temperature control systems to ensure that the coating material is melted and applied at the optimal temperature, minimizing the risk of thermal damage to the API.
Rapid Processing: The solvent-free nature of hot melt coating eliminates the need for lengthy drying times, reducing the overall processing time and minimizing the exposure of the API to potential degradation factors.   
By minimizing heat exposure and offering precise temperature control, Romaco's hot melt coating technology provides a safe and efficient solution for processing temperature- and moisture-sensitive APIs while maintaining product quality and integrity.

Does Romaco offer validation support for pharmaceutical manufacturers implementing hot melt technology?

Yes, Romaco recognizes the importance of validation in the pharmaceutical industry. They offer comprehensive validation support to assist manufacturers in implementing hot melt technology and meeting regulatory requirements. This support can include process development, equipment qualification, and documentation assistance.

What are the customization options for the spray nozzles and fluid beds in Romaco’s hot melt equipment?

Romaco understands the specific needs of different products. The granulation and coating technology “Ventilus” as well as the spraying technologies “Rotojet” or ”Flexijet” are standardized products. These technologies are adapted to the specific process needs by setting process parameters only. This provides high reliability, reproducibility and operating security as all parameters can be saved in product specific recipes.

What level of automation is available in Romaco’s hot melt coating machinery?

Romaco offers a range of automation options for its hot melt coating equipment. You can choose from manual systems for greater user control to fully automated systems for high-volume production and reduced labor costs.

How does Romaco's hot melt coating equipment handle highly viscous materials?

Romaco's Innojet hot melt systems and spray nozzles are specifically designed to handle molten materials up to a viscosity of 500 mPas. This ensures smooth and consistent material flow during the coating process. Normally, viscosity is lowered by higher temperatures. The maximum melting temperature of our hot melt systems is 90°C.