Facility

In order to adapt the world trend, the GMP factory of Health-Tech Pharmaceutical Co., Ltd spent more than ten million NT dollars to renew the software and hardware equipment of factory since 2009.

We strive to march towards the GMP goal and we also passed the factory inspection in November, 2010.

1、Facilities and equipments:

Except from forage department and warehouse, the factory is all made by using reinforced concrete. And the operation area uses the fireproof & soundproof PU panels and the epoxy resin floor, which can maintain the factory clean.

The injection-producing area:

The whole area uses stainless steel circling pipes to assure the stability of water delivery.

The independent air-conditioner makes the whole area to maintain the temperature of 18 ±2℃ in the clean-room working environment.

In this area, we separate it into several rooms: bottle-washing room, injection-mixing room, filling room, powder-filling room, sealing room, high-temperature-sterilizing room, low-temperature-sterilizing room, inspection room, and labeling room.

Bottle-washing room: We use Cozzoli bottle-washing machine to clean bottles by three procedures: filtered and compressed air, hot soft water, and pure water. After cleaning bottles, we use dry-heat sterilization oven to sterilize bacteria with the temperature of 250℃ in two hours.

Injection-mixing room: In order to assure the clarity of clean-room, we use high-efficiency laminar machine. When mixing injections, we use vacuum emulsification machine, sanitation motor, and 0.2 μ filter. Furthermore, we use UF super water filter to produce injection-used water, thus the quality of injection products is guaranteed.

Filling room: We use prompt filling machine to operate filling under the high-efficiency laminar machine.

Sealing room: We use high-speed auto lid-sealing machine to make sure that the products are sealed securely.

labeling room: We use auto labeling machine to assure that the products are labeled clearly. Powder Production Area:

This area uses independent temperature-and-humidity-controlled air conditioner and pressure deficit system to control temperature and humidity.(22±2℃, RH58%) Each room uses dust collection system to control dust closely.

We separate this area as followed: weighing room, drying room, mixing room, grain-making room, oral solution-making room, tablet-making room, capsule room, semi-finished products room, packaging room, and liquid-packaging room.

Mixing room: We have one 200kg mixing machine, one 1000kg mixing machine, one weighing machine, and one sealing machine, which assures that product-weighing, mixing, and sealing can be completed in one process work.

Grain-making room: We use 300kg auto-dryer, and solution-making, mixing, grain-making, and drying can be completed in one consistent work. Thus, we can totally match the request of high-quality and high-efficiency.

Packaging room: We have auto filling quantity-control machine, lid-locking machine, high-frequency machine, and packaging machine.

Feed additives production area:

This area uses dust collection system to control dust and air-conditioning system to control temperature.(23±4℃, below RH60%) We use 1 ton spiral mixing machine, 1.5 meter powder-sifting machine, weighing machine, sealing machine, and bag-sewing machine, which assure the accuracy of products weighing and products sealed perfectly.

2. Demarcation of area clarity and control of production process:

Our company has totally 141 different kinds of products, including injections, powders, oral solutions, external solutions, general feed additives, medicative feed additives, and feed supplements. We divide the working facility into four divisions depending on the demands of different types. They are demarcated as followed:

First Division: Laminar aseptic division, the clarity degree is under Class 100

Second Division: Aseptic room, the clarity degree is under Class 10,000

Third Division: Powder and oral solution production room, the clarity degree is under Class 100,000

Fourth Division: Feed additives, feed supplements, and external solutions division, general air-conditioner

Our factory controls the entrance of personnel and material strictly, and by doing this we can maintain the clarity of all working facilities. The room entrances of divisions with different clarity in the factory are all installed with dressing rooms and buffer rooms. We also install pressure difference indicator to maintain indoor and outdoor air pressure between 20P and 15P. The entrances of all rooms also install aerial lock devices to prevent from pollution when inner door and outer door of buffer room open simultaneously. In powder division and feed additive division, we install dust collection equipments to avoid dust polluting semi-finished products. All semi-finished products are sampled through quality control, and after passing quality control, products will be packaged. The finished products also must be sampled through quality control, and then they will be placed in the warehouse. These procedures can assure the quality of products.

3. Quality Control:

The quality control department controls materials, assures production process and quality of products, and takes charge of personnel training and equipment corrective-using.

The quality control department is divided into general laboratory, biological laboratory, instrument room, and animal experiment room. We have equipments such as ultraviolet ray spectrophotometer, atomic spectrophotometer, infrared ray spectrophotometer, auto-titrator, moisture determination balance, aseptic laminar machine, high-pressure sterilization machine, Petri box, incinerator, temperature-and-humidity-controlled machine, -80℃low-temperature freezer…etc.

4. Warehouse management:

1: Warehouses are classified as material storage, product storage, and furthermore admission check area, qualified product area, and defective product area.

2: We use forklifts to operate in order to enhance service efficiency, and also abide by the rule of“ first in, first out.”

3: From purchasing material and packing to placing products and shipping, we operate with the principle: the quality standard is always above the average.