Product Details Supplier Info More products

Biopharma Process Systems has considered vial washing in the pharmaceutical, animal health and biotech industries, with a particular focus on the Penntech RW series of vial washers.

Today, most glass vials for pharmaceutical, animal health and biotech products are of high quality.

However, after the manufacturing process, vials are subject to uncontrolled environments and are likely to become contaminated with particulates and micro-organisms.

The most effective way to remove contaminants from vials is through ‘scrubbing’ with pure water.

Most commonly used is water for injection (WFI), which has been purified to a high degree to eliminate particulates, micro-organisms and pyrogenes.

This ‘scrubbing’ is most often accomplished by high-pressure water jets.

The effectiveness of scrubbing is a function of the following factors.

First, the energy level of the WFI: the higher the WFI temperature, the higher the energy level.

High-temperature WFI (80C to 90C) is more effective in particulate removal than WFI at ambient temperature.

High-pressure water jets (5-6 bar) are more effective than low-pressure jets.

Second, the amount of WFI used per vial: the amount of WFI is subject to the size of the vial.

Obviously, larger vials require more WFI than smaller vials.

In a vial washing machine, the amount of WFI is determined by: the cycle time (or speed setting) of the machine; the number of spraying stations; the orifice of the spraying opening; and water pressure.

As WFI is part of the ongoing operational cost, it makes sense to use WFI as sparingly as possible.

Ideally, before final validation, the minimum amount of WFI per vial should be determined with different spray manifolds with different orifices.

As this is often impractical, the WFI consumption of some washers is two to four times higher than required for validation.

Although most washers are adequate in cleaning vials, not all washers are ‘created equal’.

Mechanical movements in the washing chamber generate particulates and should be kept to a minimum.

WFI supply lines must be without ‘dead legs’ and as short as possible.

Manifolds to distribute WFI should be sloping in order to drain the washer completely at the completion of a batch.

Some designs may actually cause more particulates during the washing cycle to a vial than they remove.

We can categorise vial washers into three main design types: batch washers – inexpensive, small, labour-intensive, common media manifold, wasteful, difficult to monitor, carpal tunnel issues from repetitive wrist movements; rotary washers – small, inexpensive, efficient, simple, fast changeover, versatile; and inline washers – large, expensive, wasteful, many moving parts; long changeover time.

With many years’ experience in the industry, Penntech decided to concentrate efforts on rotary vial washer designs as a response to industry demands for a smaller footprint, ever more flexible and increasingly efficient systems.

Through an innovative engineering approach and best use of modern materials and production methods, Penntech vial washers, regardless of model, are claimed to be the smallest vial washers in the industry.

Penntech accomplishes this by having all piping, instrumentation and electronics (including the electrical enclosure and HMI) mount underneath or on the frame.

Penntech vial washers are designed with minimal moving parts.

In fact, there are no moving parts underneath the vial washer base plate, no gears, no belts, no chains, no grease points, and so on.

There are two moving parts inside the wash chamber: the central column and the outfeed mechanism.

The simple design offers lower lifetime costs, faster build and near-maintenance-free operation.

Penntech has designed its vial washers for optimised WFI consumption.

Individually programmable intermittent spray valves ensure each vial format is sprayed with a specific media only as long as needed.

Recirculation packages (optional on the RW500 and RW800, standard on the RW1150) can use ~50 per cent less WFI.

Dedicated change parts, which are fast to exchange, have proven to be most efficient with a spray tube orifice size specific to the vial volume.

Traditional vial washers use a penetrating needle for air and water delivery to the inside of the vials.

This is in contradiction to the purpose of a vial washer, as anything that moves generates particulates.

Further, these needles can hit the vials, bend and cause the washer to perform outside of its validated parameters.

Non-penetrating nozzles, such as those used by Penntech, eliminate these drawbacks.

Wherever possible, components used on the RW series of washers are internationally available, ensuring that customers can resource spare parts locally with minimal lead times.

Penntech machine manuals are comprehensive and written in an easy-to-understand format, independently assessed, with detailed construction drawings and OEM part identification.

UK-based Biopharma engineers are trained in the operation and maintenance of Penntech washers.

Efficient, simple designs ensure that Penntech vial washers are competitively priced with a low cost of ownership during the equipment’s lifetime.

The RW series of vial washers are an established design, proven at many major pharmaceutical and biotech companies.

Three fully automated models are currently available, each with options to be integrated into a production line: RW-500 – footprint ~102 x 127cm, up to 7,200 vials per hour; RW-800 – footprint ~152 x 152cm, up to 12,000 vials per hour; and the RW-1150 – footprint ~140 x 178cm, up to 27,000 vials per hour.

The RW-250 (footprint ~60 x 100cm) is the latest addition to the product family and provides a low-cost, standalone vial washer designed for small batch use and start-up facilities.

Loading is manually performed, yet the anticipated maximum throughput is up to 4,000 vials per hour (operator dependant).

The RW-250 uses the identical, automated wash program of the current fully automated series of RW washers.

Biopharma Process Systems

View full profile