Ampoule Filling Lines
In the pharmaceutical industry, an ampoule is a small, airtight glass container designed to maintain the sterility and integrity of its contents. Commonly used for storing injectable medications, vaccines, and sensitive liquids or gases, ampoules protect against air, moisture, and contaminants. They are sealed to ensure product stability until the moment of use. Ampoules come in two main types: open ampoules, which are ready for filling and sealing, and closed ampoules, which require an opening step before filling. Their use is critical in ensuring safe and contamination-free drug delivery.
Filling Line Comes Under a Different Contentment System
ORABS – Open Restricted Access Barrier System
ORABS provides a physical barrier—typically constructed from tempered glass or acrylic panels—that separates the critical product zone from operators, while still allowing controlled manual intervention when necessary.
Controlled Manual Interventions: Allows manual access during production under aseptic conditions, with risk mitigation protocols in place.
Unidirectional Laminar Airflow (LAF): HEPA-filtered airflow ensures Grade A environmental conditions over the filling area.
Glove Ports: Operators can access the process area through fixed glove ports without direct exposure, minimising contamination risk.
Installation in Grade B Cleanroom: ORABS requires a background environment conforming to Grade B standards (EU GMP), supporting sterile operations.
CRABS – Closed Restricted Access Barrier System
CRABS provides an advanced containment solution by enclosing the aseptic filling area within a sealed barrier system. Building on the ORABS concept, it offers greater isolation between operators and the product zone. Like ORABS, CRABS requires a Grade B cleanroom for added safety and control.
Sealed Barrier Enclosure: The fully enclosed chamber minimises contamination from the external environment.
Environmental Control: Internal air pressure, humidity, and temperature are precisely regulated to maintain process integrity.
Recirculated HEPA-Filtered Air: Internal air is recirculated through HEPA filters, maintaining Grade A conditions throughout the chamber.
Glove Port Operation: Manual intervention is possible through integrated glove ports, under strict contamination control protocols.
- Ampoule Rotary Washing Machine
- Sterilisation & Depyrogenation Tunnel
- Ampoule Filling Line
- Sealing Mechanism
- Labelling Machine
The ampoule washing machine plays a crucial role at the beginning of the filling line by thoroughly cleaning each ampoule to ensure it is free from particles and contaminants. The machine performs a 6-step washing and rinsing process, which includes:
- Recirculated Water & Air: Ampoules are first cleaned using recirculated water, followed by compressed air to remove loose particles.
- Purified Water & Air: A second rinse with purified water ensures a higher level of cleanliness, again followed by air drying.
- Water for Injection (WFI): The final rinse is performed using WFI, ensuring pharmaceutical-grade sterility.
- Air Drying: Ampoules are completely dried using sterile compressed air.
Optional Features Based on Customer Requirements:
- Ultrasonic Washing: For enhanced cleaning, particularly in applications requiring ultra-high sterility, an ultrasonic washing unit can be added. This technology uses high-frequency sound waves in a liquid medium to dislodge and remove microscopic particles.
- Siliconization (Optional): In some applications, siliconization may be required to improve the internal surface smoothness of ampoules. A fine mist of pharmaceutical-grade silicone is sprayed inside the ampoule.
After washing, the ampoules pass through this tunnel for sterilization and depyrogenation. This tunnel is divided into three parts: Dry Zone, Hot Zone, and Cool Zone.
- Drying Zone: The ampoules are dried to remove the residual water left inside the ampoules.
- Heating Zone (Sterilization): The ampoules are sterilized & depyrogenated by heating them to a temperature greater than 300 °C.
- Cooling Zone: This is where the temperature of the ampoules is brought down to room temperature.
The clean ampoules are moved on a smooth conveyor belt system. This automated transfer carries the ampoules gently to the filling and sealing machine, preventing damage or contamination. It also ensures continuous and efficient production.
Controlled Environment (ORABS/CRABS):
The filling happens in a highly sterile area protected by ORABS (Open Restricted Access Barrier System) or CRABS (Closed Restricted Access Barrier System). These systems use filtered air, glove ports, and strict access control to keep the area clean and prevent germs or dust from entering.
Accurate Liquid Filling:
The ampoules are filled with medicine using precise pumps, such as peristaltic or rotary piston pumps. This ensures each ampoule gets the exact right amount of liquid without overfilling, underfilling, or air bubbles.
Nitrogen Flushing:
Nitrogen gas is injected into the ampoule before and after filling. Before filling, it removes air from inside the ampoule. After filling, nitrogen helps prevent oxidation, which keeps the medicine stable and extends its shelf life. This is especially important for sensitive medicines.
After the ampoules are filled with medicine, they are sealed to keep the liquid sterile and safe. This happens at the machine’s sealing station.
Flame-Based Glass Sealing:
Each ampoule is sealed by melting its glass tip using a controlled flame. The glass neck softens and melts, creating an airtight seal that prevents contamination or leaks.
Burners and Preheating:
Before sealing, the ampoule’s tip is gently preheated. This prevents thermal shock and helps create a smooth, even seal. The burners are carefully positioned to heat only the neck of the ampoule.
Use of Oxygen and LPG:
A mix of oxygen and LPG (liquefied petroleum gas) produces a clean, high-temperature flame perfect for melting glass. The flame’s strength and direction are precisely controlled to ensure consistent sealing for every ampoule.
The ampoules are gently moved into the rotary labelling machine, where they are held securely and rotated for even and accurate label placement. The rotation helps ensure that the label is wrapped around the ampoule in the right position without wrinkles or misalignment.
Automatic Label:
The machine picks up pre-printed self-adhesive labels and sticks them onto each ampoule. This process is fully automatic and happens at high speed, which helps save time and ensures uniform labelling across every unit.
Product Flow
