The Ophthalmic Production Process : Production

Santen operates a world-class pharmaceutical production system delivering products to patients around the globe. Here, we briefly explain our process of manufacturing.

The ophthalmic production process (Production)

Water purification

STEP1 Water purification

Preparing Water.

We consider the preparation of water, a large component our products, to be one of the most crucial step in the production process. First, we take water that meets drinking standards and remove impurities through chemical processing. This processed water then undergoes ion-exchange treatment, ultrafiltration(*1) and finally distillation before we consider it to be pure enough for production purposes.

  1. A method of water purification employing semipermeable membranes to remove colloidal particles, microorganisms and macromolecules.

Formulation

STEP2 Formulation

Producing the Ophthalmic Solution from Water and Raw Ingredients.

The purified water is pumped through airtight and aseptic pipes to the formulation tanks. Raw ingredients that have passed inspection on delivery are subject to an air shower to clean away unwanted particles and then stored temporarily. Then, the ingredients are precisely weighed and charged to the formulation tanks in a specific order. Although formulation is computer-controlled, operators still manage the overall process and keep a vigilant eye on the system to ensure quality.

Filling

STEP3 Filling

All Bottled Up.

After formulation, the resulting solution undergoes sterile microfiltration and is then sent to the blow/fill/seal(*2) (B/F/S) machine via airtight aseptic pipes. Because this step is the most vulnerable to bacterial contamination, the air quality in the filling zone is mainteined to a degree comparable to standards for operating rooms.

  1. In this technique, small liquid containers are formed, filled and then sealed in a continuous process while maintaining sterile environment.

Inspection

STEP4 Inspection

Thorough Checks for Perfect Products.

After the B/F/S machine rolls out solution containers in a sheet formation, a cutting machine slices out individual bottles which are sent to the inspection line. Here, inspectors check the products on the conveyor belt for any irregularities. At this point, the individually bottles still lack a spout. The spout component is crafted after checking for scorching left by the cutting machine. This is done by molding the nozzle and head portion in a cleanroom with Grade A air quality, the standard used in operating rooms. The container is then capped immediately after the tip is attached. Every product undergoes checks at each stage by devices that test the nozzle, the spout opening and the product weight. The products are then sent to packaging.

Packaging / Storage

STEP5

Getting Ready to Travel to Help Patients.

In this process, a machine fits shrink labels onto containers sent from the previous process. While this is happening, inspectors remove samples from the line to examine their quality. Products that have the required specifications are placed in small boxes after confirming serial numbers and expiration dates have been properly printed. These boxes are packed in cardboard boxes and kept in climate-controlled storage. Further tests are then conducted on the sample products and upon assurance of quality control checks on sterility and chemical quality until data from tests conducted in each process are obtained. If the results of these tests for asepsis, physical chemistry, water quality, environmental monitoring and other items are deemed satisfactory, the products are finally ready for shipment.