The manufacture of oral liquids syrups involves several essential tools and requirements. Each requirement is necessary and plays a vital role in manufacturing. Furthermore, the manufacturing process is closely observed by certified professionals. Albeit qualified professionals are mandatory, the workers involved in the overall process must also be fully trained. Because even a tiny change in the raw materials or the process can cause heavy loss to the oral liquid supplier, it can damage the entire content. The process requires a list of assets and materials to comprehensively view the oral liquids syrups requirements.
It had an adequate infrastructure designed, constructed, and maintained to prevent contamination and mix-ups in the production process. In addition, the infrastructure should have a double-door airlock facility at the entry. To prevent flies from swooping in, it should also have installed a flycatcher or air curtains. The drainage system should be built in an order that doesn’t allow the waste materials to return to the facility, and their top needs to be sealed effectively. It needs to be cleaned regularly after each batch of production.
The purified water must be specified and closely monitored to keep the chemical and microbiological quantity constant. Appropriate measures such as recirculation, UV treatment, treatment with heat, and sanitizing agents must be taken to avoid microbial proliferation. Furthermore, the absence of pathogens shall not exceed 100 CFU / ml (according to appendix 12.5 of IP 2018).
As mentioned earlier, the workers within the manufacturing facilities need to be heavily trained and subtly follow the rules and regulations involved in the process. Manufacturing personnel must wear clothes that aren’t made of fiber, prone to shedding small fiber particles, leading to contamination. They aren’t allowed to bring bags or packages made out of fiber within the area where products are exposed to open air.
Extra care is needed to maintain the homogeneity of the emulsion by using appropriate emulsifiers and suspensions during the process of filling. Mixing and filling must be monitored to prevent any troubleshooting. It also requires special care during the initial phase of the filling process to prevent any stoppage that might be caused due to any inconveniences. And in the final phase of the filling, ensure the product is homogeneous. The temperature of the filling area should not exceed or succeed 30 degrees centigrade.
Furthermore, the packaging area should have a constant air supply through 5 – micron filters. Regarding packing, the oral liquid supplier must take appropriate measures when the finished product is not packed immediately. The maximum time of storage and storage conditions need to be explained in the master formula. In addition, the maximum storage time of a product is essential for validation.