The use of disposable manufacturing equipment in pharmaceutical production and greater need for containment equipment were recurring themes at the Interphex show in Philadelphia last week, and both were addressed by new equipment from Bosch Packaging Technology.
On the disposable side Bosch introduced its Prevas dosing system for filling liquid pharmaceuticals into vials, ampoules and syringes, noting that it is the first product on the market that comes pre-assembled, pre-sterilized and pre-validated.
"This is a unique offering, [as] we provide validation along with the system" said Jeff Jackson, director of product management at Bosch Pharma USA. "We offer a certification on sterility, particulates, extractables and leachables, etc, as well as shelf-life," he noted, and this makes it a ready-to-use system that users will find it easy to implement.
It also takes the use of disposables firmly into the downstream end of the bioprocessing path; most single-use items are designed for use in upstream processing, such as bioreactors etc.
Prevas takes the form of a bulk product bag, a positive displacement rolling diaphragm pump (which is the heart of the system and the only disposable pump of this type on the market), filling needles and tubes. It attaches straight to the filling system using sterile connectors.
The main benefits are similar to those seen with other disposable technologies, said Jackson. It eliminated the preparation steps involved with stainless steel kit, such as cleaning, assembly, and disassembly, autoclaving and clean-in-place (CIP) or sterilize-in-place (SIP) operations, as well as associated labour and material costs.
A quick changeover also improves productivity, and use of disposables eliminated the risk of contamination between batch runs - a key consideration as the pharmaceutical industry strives to make its production facilities more flexible and cost-effective.
Other advantages of the system include the use of disposable needles - which are guaranteed straight every time unlike their stainless steel counterparts. The latter are also notoriously difficult to clean.
Jackson noted that the system can run at low speeds for syringe filling as well as higher speeds more suitable for vials, and has been shown in pilot studies to offer fill accuracies equivalent to stainless steel pump systems. The unit can run at both clinical and production scales, making scale-up easy, he added.
Meantime, Bosch has tapped into the trend toward the development of high-potency compounds in the pharmaceutical industry with a new capsule-filling machine that offers 'true' containment and improved operator safety.
Introducing the GKF HiProTect system at Interphex, Jens Mack, vice president of Bosch's Pharma Solid division, said it is the first to offer all aspects of capsule filling - filling, check weighing and washing - all within one machine.
There has been a dramatic increase in the pharmaceutical industry for the development of high-potency and high-toxicity active pharmaceutical ingredients (APIs) such as cytotoxics, and this has led to rising investment in high-potency production that has pushed containment issues to the fore.
Occupational exposure to even tiny quantities of some cytotoxics can be life-threatening, and the need for operators to wear air suits, masks and other safety equipment makes working conditions unpleasant and cuts down the length of each operators shift.
The GKF HiProTect "answers the growing need for pharmaceutical researchers and manufacturers to be completed protected from active substances during operation, maintenance and cleaning," said Mack.
The filling station processes powder, tablets, pellets, liquids and even combination formats, according to Bosch, and the unit has a number of features that improve operator safety. For example, it operates at negative pressure inside the containment area, so in the event of a leak air would be drawn into the machine rather than out, and all adjustments are made via glove units.
The GKF HiProTect is also designed to save time and money. Automated cleaning within the unit saves operator time, as does the ability to add on filling units without downtime, and an automated loader means that it can continue to run if an operator is absent.
In addition, built-in quality control functions such as no cap/no fill prevents product loss and internal contamination, and a sophisticated check weighing system that can check gross, net or individual capsule weights ensures product quality and automatically ejects out-of-specification capsules.
"The fully-integrated check weighing technology, automated cleaning system and flexibility in filling materials make the GKF HiProTect a true innovation," said Felix Nink, product manager at Bosch Packaging Technology.