Blog

Introducing Fabtech's Sterilising & Depyrogenation Tunnels

There are two main techniques used for depyrogenation - batch and dynamic. As not all products can withstand the high temperatures required for the depyrogenation process, batch depyrogenation is carried out in static ovens, especially for metal containers and heat sensitive solutions where the products are placed in metal crates and exposed to high temperatures. Dynamic depyrogenation involves the use of a sterilising-depyrogenation tunnel, where products are transported over a continuous band through the different heating zones of the tunnel.

2 minute read

Mainly used in the sterilisation of vials for aseptic filling, this process is also useful when sterilising assembled and packaged materials, as heat conduction does not require the contact of the product with steam or water. The depyrogenation process varies depending on the load and product being sterilised.

Sterilising & Depyrogenation Tunnels are an integral part of the continuous automated high yield injectable line. They are used to ensure glass containers are sterilised and depyrogenated for filling operations as per 21 CFR part 211.92 guidelines.

While in the tunnel, glass containers are subjected to controlled heating and cooling cycle under ISO 5 cleanliness levels. The temperature of the glass container is raised and maintained for a prefixed value - the time required for the necessary reduction of the bio-burden within the tunnel enclosure. Downstream, the tunnel is integrated with a washer, and a filling machine upstream.

The Sterilising & Depyrogenation Tunnel comprises an endless variable speed conveyor; varying air modules including pre-heat, sterilising and cooling and stabilising; electricals, instrumentation and control system; as well as an interface between the washer-tunnel and tunnel-filling machine.

Fabtech's Sterilising & Depyrogenation Tunnels feature unidirectional air flow, process temperature progression curves, and reduced sterilisation times. The design allows for easy changes between different container types and configurations. The tunnels deliver repeatable accuracy required for successful validation, qualification, and reliable production capacity, and the controllable and reproducible process parameters simplify validation. There is easy access to tunnel interior for cleaning and maintenance.

We also offer the sterilisation of cooling and stabilising module by dry heat as optional feature.

The entire operation is controlled through PLCs which is 21CFR part 11 compliant with audit trail, featuring manual, automatic and night mode operations.

The Sterilising & Depyrogenation Tunnel has built-in monitoring and controls system for proper operation and appropriate interlocks with washer-filling machine to ensure smooth operation of integrated parenteral line for both vial and ampoules.

Every Sterilising & Depyrogenation Tunnel manufactured by us is subjected to rigorous testing as part of standard SAT protocol including 1. Velocity measurement and profile 2. HEPA integrity testing ( PAO test ) 3. Non- viable airborne particle count ( Cleanliness level ) 4. Temp profile ( Heat distribution and penetration ) 5. Endotoxin study 6. All interlock and controls

These tests are performed as per mutually agreed SOP and standard guidelines.

If you would like to know more about our Sterilising & Depyrogenation Tunnel or the SAT testing process, fill out the form below to request a call back from one of our experts.

Tell us what you are building and where, and an engineer will reply within 24 hours

Start a conversation

Related and next step

Start a conversation

Tell us what you are building and where. An engineer will read your message and answer it. We reply within 24 hours.

What helps us reply faster
  • The process. What you will make, in what dosage form, and at about what scale. For example: tablets, capsules, liquids, sterile injectables, API or biologics. Your answer changes almost every later step of the project.
  • The containment requirement. If the material is potent, tell us its OEB band. OEB (occupational exposure band) is a grade that shows how little of a material a worker can safely be exposed to. This one figure decides if you need a booth, an isolator or a contained suite. Their costs differ by an order of magnitude, which means about ten times.
  • The market. Tell us which regulator will inspect the facility. Also tell us the electrical supply at the site: 50 Hz or 60 Hz. The format of the documents and the specification of the equipment both depend on this.
  • The state of the site. Greenfield (an empty plot), brownfield (a site used before), an extension, or a retrofit into a running plant. A retrofit means new work inside a plant that is still in production. It is a different engineering problem from an empty plot, and usually a harder one.
  • Your timeline. Include any regulatory or commercial date the project has to meet.

For a single piece of equipment rather than a facility, tell us four things: the machine, the material, the throughput and the destination market. Throughput is how much material the machine must process in a set time.

Telephone: +91 22 6554 0300