Rotary filling machine with sealer and depyrogenation and sterilization tunnel for injectable glass ampoules in 316L stainless steel Bausch with CFR 21

Rotary filling machine with sealer and depyrogenation and sterilization tunnel for injectable glass ampoules in 316L stainless steel.

Comprises:

- Automatic rotary filling machine and sealer for glass ampoules for human injection lines.

Manufacturer | Brand: Bausch.

Model: 506.

Year: 2022.

Nominal production capacity: up to 24,000 items per hour, depending on the ampoule size.

Equipment complies with CFR 21 PART 11.

With flame/torch sealing for glass ampoules (heat sealing).

For human pharmaceutical industry, intravenous injectable medications, vaccines, sterile biological products, anesthetics, hormones.

For veterinary pharmaceutical industry, intravenous injectable medications.

For 2 ml and 5 ml glass ampoules.

Liquid dispensing system accuracy +/- 0.5%.

It has 8 AISI 316 L stainless steel filling needles.

The needles are controlled by AISI 316 L stainless steel rotary plunger pumps (180° rotation).

The filling system features an anti-drip system.

The pumps in the product dispensing system are driven by two separate servo motors (one for vertical movement and the other for rotation).

The filling needle is immersed in the product to prevent the ampoule walls from becoming wet.

It has separate burners for preheating the ampoule tips and burners for opening the ampoules and/or enlarging the opening.

It has a flow meter for indicating and adjusting the gas/oxygen mixture for the burn.

The neck of the ampoule is heated by a direct flame, forming the "drop head" or "dome" of the glass ampoule.

A gripper system extracts the ampoule tips when the temperature sufficient to melt the glass is reached, with separate burners and a chute.

Product is fed via a 320 mm wide and 900 mm long motor-driven conveyor belt with pushers, a minimum accumulation sensor, and automatic production resumption.

It features an AISI 316 L stainless steel intermediate tank with a 10-liter capacity for dosing liquid products with rotary plunger pumps, including:

Intermediate tank with level control.

It features a post-gassing station.

The equipment has an aluminum and stainless steel machine base.

It features an aluminum table with a stainless steel cover.

Infinitely variable movement via a direct current motor.

It features a polycarbonate machine guard.

It features safety monitoring after a door is opened during production.

- Stainless steel depyrogenation and sterilization tunnel for glass ampoules/vials.

Manufacturer | Brand: Bausch.

Year: 2022.

Equipment is CFR 21 part 11 compliant.

The depyrogenation machine has three main zones: preheating, depyrogenation, and cooling.

The preheating zone gently heats objects by vertically flooding them with sterile air.

It features a laminar flow unit with a pre-filter, sterile filter, and fan.

It features a safety thermostat to prevent overheating in the preheating zone.

In the sterilization zone, objects are heated by a low-turbulence airflow.

The air is heated by stainless steel tubular heaters.

It features a safety thermostat to prevent overheating in the preheating zone.

In the cooling zone, objects are cooled by a laminar flow of filtered air.

It has a chute to collect broken glass at the outlet, for cleaning the channel.