The production plant has seven production lines located in three separate buildings, in which the operations of formulation, packaging and conditioning are performed. The plant has high-tech equipment and systems, which allow to manufacture various dosage forms:
Ophthalmic Solutions from 1 mL to 15 mL.
Preservative-free ophthalmic Solutions from 5mL to 10mL.
Preservative-free ophthalmic Solutions in single dose 0.5 mL.
Pre-filled syringes 1 mL.
Ophthalmic Ointment from 3 g to 10 g.
Ophthalmic Suspension from 1 mL to 15 mL.
Automated systems have data acquisition and analysis processing which provide safety, consistency and repeatability conditions for the processes, guaranteeing the continuous acquisition of high quality products.
Sophia also has state-of-art support systems to ensure that all services meet the established pharmacopoeial requirements, these systems are:
Purified Water (PW).
Water for injection (WFI).
Filtration and distribution of Nitrogen.
The formulation of a Production lot is carried out through a SCADA (Supervisory Control And Data Acquisition) system, which allows qualified personnel for automatic operation of tanks and reactors. The packaging of ophthalmic products is done in ISO 5 and 6 class aseptic areas with the support of the HVAC (Heating Ventilation and Air Conditioning) computerized system.
The ophthalmic products filling machines provide the precise dosage of each unit, the monitoring system and process control ensure compliance with filling specifications.
Variable data such as lot number, price and expiration date are printed and reviewed at the conditioning stage by Optical Character Recognition (OCR) devices.
Logistics and Warehouse
The facility is planned to follow unidirectional flow processes, starting in the warehouse of supplies, from the manufacturing processes in the plant to the finished product warehouse and shipping.
To meet the current reliability, speed and efficiency needs to serve our customers, Sophia undertook the challenge to get to the forefront of technology in logistics processes, since the supplies are received in the warehouse until the products are delivered to the customers, this is possible thanks to SAP (Systems, Applications and Products in data Processing) and its WM (Warehouse Management), HU (Handling Unit) and LE-TRA (Logistics and Transportation) modules. In addition to the incorporation of new Vocollect® System (Voice Technology) for picking and packing of finished product, use of barcodes and RF devices to increase productivity and improve response time for our customers.