By Marta Romaniuk & Richard Lewis- Biopharma Group, Winchester, UK. in conjunction with John Rakucewicz – Kinematics & Controls Corporation, Florida, USA.
Increasingly, industry appears to be driven by a manufacturer’s demand for ‘stream-lined’ processing, whilst maintaining the level of product integrity expected by their customers – whether this be taste, consistency, texture, or API activity.
The field of accurate powder filling is a good example, where the propensity for companies to move away from more time consuming, laborious, and in some instances, inefficient procedures has become far more pronounced. In this environment, every effort is made to save material, eliminate waste, and increase operational efficiency, whilst satisfying the regulatory and EH&S requirements. As a result, a vast amount of technology, and various methods have been applied in an attempt to accurately measure and dose specific volumes of powdered material.
However, due to the slow and arguably, inaccurate nature of many traditional techniques such as hand filling, operators have sought new ways to maximise efficiency, minimise loss of product efficacy, and, ultimately, protect their sustainability and position in the market place, economically. For instance, while the net weighing fillers prove to be accurate, they are particularly slow in operation. The time taken to achieve an ‘acceptable’ volume of target material, with these ‘simpler’ dose methodologies of manual hand filling/weighing techniques appear to have become out-dated in the contemporary fiscal and time dependent climate, with preference towards the implementation of modernised technology.
This is undoubtedly due to the fact that filling by hand means and operator must literally take up product with a spoon, spatula, or similar, before weighing to ascertain how near, or more typically, how far away, they are from the target volume. Of course, the length of time per dose can obviously be considerable, and creates a high probability of variance from dose to dose.
Henceforth, the popularity of using powder filling instruments to assist has expanded across many markets, from pharmaceutical to diagnostic reagents, cosmetics to powdered metals and food.
Another aspect to consider is the evolution of product understanding, to, again, satisfy regulatory and customer demands. For example, quality by design (QbD) is a model, which has become quite pervasive in manufacturing environments, driving the end user to consider and identify individual but inherent material characteristics, prior to application of suitable filling technology.
This nature of understanding may be accompanied by product reports to convey the reason a particular product is dispensed in a particular way e.g. corroborative data that can then be reviewed by auditing regulatory bodies. A level of enhanced documentation that will definitely serve to benefit both the product manufacturer, and their customer. For these reasons, in depth review of specific sample properties, process requirements and techniques are now regularly requested and carried out to gain that required knowledge. The goal of this assessment is to ensure consistent and accurate extraction of the required dose at a satisfactory processing speed and end-product quality, accompanied by a documentation trial. Users therefore need a partner willing to provide such a level of detail.
Where traditional auger fillers may have their place in large doses filling applications of dry powdered or granular products, they lack the level of precision required for the delivery of small incremental doses with close-tolerance, repeat accuracy.
At the other end of the spectrum, the volumetric powder filling approach has a proven record in the delivery of highly accurate, reproducible, and swift dosage. Here, material is drawn-up in to an orifice of known dimensions using an integrated vacuum system. The optimal filling system and procedure is then determined by the application for which they are used, and on the properties of the process material, such as:
- Bulk density
- Free flowing or non-free flowing
- Coarseness, concentration gradients and uniformity of powder
- Container type
The measuring tool selection has to consider both your dosage, plus the size and shape of primary containers, which might, in turn, affect the operator’s ability to dose their desired volume per minute, hour, or the working day.
In addition, the variation in size of different powder particles, from several microns to more granular volumes, must be taken in to account during the selection of not just the base machine and volumetric dosing barrel, but the filter type too, which may also improve the dosing capacity.
In some cases, the presence of larger filter pores i.e. 40µm as opposed to 20µm, may improve the airflow through the dosing gun and aid in the products compaction, thus reducing potential product waste by simultaneous dose and filter purge. During the dosing process, the residue powder inside the dosing chamber and on top of the filter will be expelled accurately by applying a user-defined pressure.
The Kinematics & Controls Corporation (Kinematics), is a world leader in this volumetric technique, applying their expertise in field of engineering to design of volumetric equipment. The Kinematics HQ is based in Florida, USA, but has a strong European presence through its partnership with Biopharma Group.
Kinematics attention to detail and expertise in the field helps to set them apart from other powder filling companies. The first step is a comprehensive sample test protocol, designed with six-sigma levels of quality in mind, recommended to identify the key powder and container characteristics. The outcome should provide a clear understanding of the following:
- The level of vacuum required to pick up and adequately pack material, without compromising its structure
- The depth of the product in the given dosing ‘gun’ to calculate the volumetric measurements
- The level of tolerance expected when applying these aspects to the dose
- A full written report can then be issued, for customer interpretation
Please note, it is prudent we highlight that when these details are identified they only need to be applied once, allowing the operator to conduct a working shift of accurate and repeatable dosing for that individual sample.
These simple, accurate, high-speed and cost efficient Kinematics powder fillers have a unique, rugged construction modular design where the entry-level machine 4400/VC console forms part of both the Model 4400/TX & the Model 5500/TX. All systems are capable of running for long periods of time, with low maintenance while accurately measuring and dispensing the powdered material in to desired containers.
Various Kinematics systems are available to simplify operation and increase productivity, as described, below, and all are supplied complete with extensive build diagrams, wiring configurations, and FDA approved parts, where required:
- Manual bench top system- requires one hand to operate the filling gun, dosing via foot pedal or button
- Suitable for filling pouches and great for rigid containers
- Low cost
- Filling volumes up to 3K-4K fills/day
- Dosing range between 2mg and 150g
- Modular system- forms part of both the Model 4400/TX & the Model 5500/TX
- Fully automated benchtop system
- Great for rigid containers and filling pouches
- Filling volumes up to 8K-10K doses/ day
- 4″ dia. shuttle disk limits maximum dose size to approximately ~40 gm.
- Integral hopper and stirring mechanism, included
- Automated system- direct drive technology- programmed stepper motor drive, bench top operation or can be integrated with other automatic machine functions
- Five (5) modes of operation- Configure your 5500/TX the way you need it – this includes capability to integrate in to a larger, fully-automatic filling system, operating in a symbiotic “hand-shaking” mode with the host system’s PLC
- User selectable from full-colour, touch screen HMI
- Integral hopper and stirring mechanism
- Great for rigid containers and filling pouches
- Filling volumes up to 8K-10K doses/day
- 6″ dia. shuttle disk raises maximum dose size to approximately ~180 gm
Consumer feedback suggests that it is the relationship of available system flexibility coupled with the high quality construction of the machines, which has seen the Kinematics brand become an established market brand.
By identifying a suitable filling solution for target powdered material at the outset, users can minimise potential for operational problems over time, significantly reducing manufacturing expenditure, while building the client confidence in scale up capacity.