BY PACKAGING


Ampoules

Ampoule - A container sealed by fusion and to be opened exclusively by breaking. The contents are intended for use on one occasion only.

Important Characteristics of Glass as an Adequate Material for Drugs

Characteristics

Importance

They can filter specific wave lengths

Packaging of photosensitive substances

High fusion point

It tolerates the sterilization process (by vapor at 1,210°C, and dry at 2,600°C) – microbiologic control.

Excellent chemical resistance

It hardly interacts with its content

Impermeability

Important barrier between media

Smooth surface

Easy to clean

Rigidity and stability

Withstands vacuum

It follows a structural pattern of a mold

Ease to make several containers

Types of Ampoules

Pharmaceutical Ampoules

  1. One Point Cut (OPC) Ampoules – a small incision (cut) is placed in the constriction of the ampoule with a disc. A small colored dot marks the position of the breaking cut.
  2. Colour Break Ring (CBR) Ampoules – a colored enamel ring is applied around the constriction.
  3. Score-ringed Ampoules – a disc marks the glass surface all around the constriction.
Ampoule Cleaning
  • Cleaning via ultrasonic washing machine

    This machine is mainly used in the pharmaceutical industry for small volume ampoule cleaning.

  • Cleaning via ampoule sterilization dryer

    Mainly used on the injection linked production line of pharmaceutical factories. It can continuously dry, sterilize and remove pyrogen of the washed ampoule.

  • Cleaning carousel

    The rotating gripper/transport system accepts the container smoothly and transfers to the different cleaning stations in continuous motion, where the containers are treated for pre-determined period of time.

  • Cleaning of inside and outside with purified water

    The first cleaning station is operated with purified water, which can be recirculated. The same water quality is applied for filling the containers in front of the ultrasonic bath and the needles of the first cleaning station. By that the fresh water consumption is reduced to a minimum. A senor in the purified water tank controls the water level. A permanent renewal of the water is achieved by collecting the overflow from the final rinse station.

    All water going into the needles is filtered with particle filters, which are placed in the water feed system. An additional wire cloth filter positioned in the drain of the tank in front of the recirculation pumps hold back macroscopic particles such as glass splinters, which could damage the pumps.

  • Cleaning with fresh water (WFI)

    It performs a final rinse of the inside of the containers in order to remove particles which were detached from the glass surface durin prior steps. This step is more dilution than mechanical removal.

  • Drying with sterile air

    To avoid residues from drying of water droplets on top of the glass surface, residual water is removed with pressurized sterile filtered air.

  • Siliconization

    Performed at the end of the cleaning cycle. The goal of siliconization is a homogenous coating of the inside of the container with a silicon layer, which will be cured as an integral part of the sterilization and depyrogentaion process in the heat tunnel.

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Image courtesy of BAUSCH Advanced Technology Group

 

Ampoule Depyrogenation

Involves the sterilization of the ampoules with hot air and constantly recirculated. The ampoules are then cooled gently before they are automatically transferred into the next production process.

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Image courtesy of BAUSCH Advanced Technology Group

 

Ampoule Dosing

  • Peristaltic Pump Filling

    The peristaltic pump uses a rotor in which multiple rollers are mounted. Partially surrounding the rotor is a stationary, curved shoe or “anvil”. A flexible, hollow tube (usually silicone rubber) is pinched between each roller and the shoe. As the rotor rotates, fluid inside the tube is driven forward as the pinched portion of the tubing advances.

  • Piston Pumps

    The piston pump, along with the rolling diaphragm pump, may be compared to a syringe in that they both employ a moving piston inside a stationary cylinder to displace a precise amount of liquid. As the piston moves upward, liquid is forced out of the pump and when it moves downward, liquid is drawn into the pump.

  • Rolling Diaphragm Pump

    The rolling diaphragm pump uses a flexible membrane (diaphragm) attached to the pump body at its outside diameter and to the piston at its inside diameter. A space between the piston and the body internal body cylinder allows the diaphragm to be “doubled” and to “roll” as the piston moves up and down. Vacuum is applied to a port in the lower portion of the pump body to maintain the shape of the diaphragm and to pull the piston downward on the refill portion of the filling cycle. Typically, the product supply has a slight overpressure.

Ampoule Filling

  • Time Pressure Filling

    A time pressure filling system in its simplest form, includes a product supply vessel under controlled pressure, a valve to open and close the product flow from the tank to the filling needle, and a clock or timing device to repeatedly control the amount of time that the valve is open.

  • Fill by weight

    The product supply tank may or may not be pressurized, and a flow orifice may be used to improve repeatability.

  • Mass Flow Filling

    The product supply tank may be pressurized at a control pressure, or may use a precisely controlled liquid level (gravity feed). For small fills, common in pharmaceutical filling, a pressurized system provides more precise fill volume control and acceptable cycle rates.

  • Gravimetric Filling

    A gravimetric filling system is simply a system that uses gravity, or a controlled liquid height, to provide a consistent pressure at the metering device near the filling needle. A simple time pressure filling system or a fill by weight system may be gravimetric. These system use a “clock” and a valve (time pressure) and a scale and a valve (fill by weight) for metering doses.

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Images courtesy of BAUSCH Advanced Technology Group

 

Ampoule Labelling

Containers are fed from an upstream machine then gently transferred to the labeling station and applied to the containers by smoothing belts and rollers.

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Images courtesy of BAUSCH Advanced Technology Group

 

Ampoule Tray Loading

Products are collated onto tray banks, hence product stabilization is established and controlled throughout the process.

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Images courtesy of BAUSCH Advanced Technology Group