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Typical pharmaceutical machinery - aseptic filling of ampoule and vial

2023-07-14

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Marya

This is the production line of ampoule, which is generally composed of three single machines: vertical ultrasonic cleaning machine, tunnel dryer sterilizer, and filling and sealing machine, and is divided into three working areas: cleaning, drying and sterilization, filling and sealing.

1. Ampoule washing drying filling sealing production line

Have you seen a similar small bottle before? When giving an

injection, the nurse first scratches it to break it open, and then uses a

syringe to suck the injection liquid inside. This small bottle, also

known as an ampoule, is generally used to hold injection

preparations or high-purity chemicals that must be isolated from the

air.

But have you ever thought about how the medicine in the ampoule gets in?

Please read the following introduction ↓↓↓

This is ampoule filling sealing production line, which is generally composed of three single machines: vertical ultrasonic cleaning machine, tunnel dryer sterilizer, and ampoule filling and sealing machine, and is divided into three working areas: cleaning, drying and sterilization, filling and sealing. During operation, more than 20 processes can be completed, including spraying water, ultrasonic cleaning, bottle clamping by manipulator, overturning bottle, water flushing (inside and outside the bottle), air flushing (inside and outside the bottle), preheating, drying and sterilization, cooling, (air pre-flushing), filling, (nitrogen post-filling), preheating, wire drawing and sealing.

Next, we will provide a detailed introduction to the production process of ampoule:

Step 1: Cleaning and sterilization

Initially, ampoule bottles are open and must be cleaned and rinsed with ultrasound before filling. Ampoule must also be dried and sterilized at a high temperature of 300 ℃ ,being used for filling medicine after cooling.

Step 2: Filling

And then ampoule will queue up with ampoule filling machine to be sent for filling. One row of ampoule bottles can be filled with quantitative liquid medicine once.

Step 3: Wire drawing and sealing

The mechanical arm clamps the upper part of the bottle opening, heats the middle part with a high-temperature flame, and pulls it to break. At the same time as the glass blows, the glass melts and solidifies immediately to form a sealing cover.

Ampoule itself are light weight, have good sealing properties, good mechanical properties, and are convenient for storage and transportation. However, ampoule also has certain hidden dangers:

① Defective ampoules or incorrect operations can cause the bottle to break when opening the ampoule, resulting in injuries to medical personnel and the possibility of glass fragments falling into the liquid, causing pollution and causing harm to the human body.

② When ampoule packaging injections are administered, the solution is exposed to air without cleanliness requirements, and particles and microorganisms in the air can contaminate the solution, posing potential hazards to patients.

 

 

2.  Vial washing drying filling sealing production line

Therefore, currently in the medical field, another small bottle - vial - is gradually replacing ampoule.

The vial is a small bottle sealed with a rubber stopper, available in brown, transparent, and other types. It is usually made of glass and was originally mainly used to hold penicillin, hence it is called "vial". Compared to ampoule, vial has a thicker body and are sealed with rubber stoppers (with a simple process and high yield), making it safer during use and difficult to contaminate medication inside the bottle.

The picture above shows the vial washing drying filling sealing production line, which generally consists of vertical ultrasonic bottle washing machine, tunnel dryer sterilizer, filling and stoppering machine, and capping machine. During operation, more than 20 processes can be completed, including spraying water, ultrasonic cleaning, bottle clamping by manipulator, overturning bottle, water flushing (inside and outside the bottle), air flushing (inside and outside the bottle), preheating, drying and sterilization, de-pyrogen , cooling, (nitrogen pre-filling), filling, (nitrogen post-filling), stopper unscrambling, stopper pressing, cap unscramble, and capping.    

Here is also a detailed introduction to the production process of vial:

Similar to ampoule, it need to be rinsed thoroughly inside and outside with distilled water before filling;

It also needs to be dried and sterilized at high temperature, and used for filling drugs after cooling.

Vial filling machine for filling medicament, one row of vial is filled at a time.

Adding stoppers and capping, the next step will be different. The filled vial will be covered with a rubber cap;

Then the vial is covered with an aluminum cap and capped to complete the sealing.

The above is the entire process of aseptic ampoule washing drying filling sealing production line and vial washing drying filling sealing production line. During the drying cleaning and drying sterilization processes, it is necessary to be completed in a clean environment, which needs to use the gas filtration devices. The Dwyer differential pressure gauge and differential pressure transmitter are used to detect the differential pressure value at both ends of the strainer in real time, in order to prompt on-site engineers whether the strainer used to filter gas has been blocked and start the reverse blow device or directly replace the strainer.