Bora has packaging facility to package sachets (Tainan), blisters (Tainan), tablet and capsule products. The entire packaging area is divided into primary and secondary packaging areas. Primary packaging area is designed to meet ISO 8 requirement for finished products are packed into bottles with desiccants, sealed and capped. Packaging rooms, gowning rooms, and support rooms (equipment cleaning, drying and storage rooms) are physically separated and cascade of pressurization system is used to control dust migration and prevent cross contamination.
Secondary packaging area is a controlled area for final product filled bottles are labeled and packed into labeled cases. Air in primary and secondary area is supplied by two separate Air Handling Units (AHU) due to different air classification. The environment temperature and relative humidity is controlled and monitored using calibrated instruments, indicators and controllers.
Bora Packaging Lines are designed for bottle packaging of oral solid dose products. Temperature in packaging areas is maintained thermostatically at 22 ± 3℃. The relative humidity of primary packaging area is maintained at range not more than 60% RH, while secondary packaging area not more than 65% RH.
The Optel TrackSafe non-serialized mode/serialized mode and aggregation have been validated. The Optel TrackSafe allows the serialization/aggregation of bottles/ cases/ pallets and registers serialization information for product traceability.
Bora Zhunan is also adding Level 4 serialization system to our packaging lines and will be capable of generating own serial numbers for all the packaged products in Q1, 2019.