Frequently asked questions

The dosing principle is called tamping pin method. The tamping pin principle is applied like so: powder is compacted step by step in the dosing volume until a plug of defined density is formed, which is then transferred into the receptacle.

Yes, it is. This dosing method is essentially the same as drum dosing and pin dosing, which are the most commonly used techniques for micro-dosing powders in inhalation devices. What all these methods have in common is that a defined volume is completely filled with powder that has been compacted to a specific density. The method used for compacting the powder is irrelevant. However, many scientific publications state that the tamping method is not suitable for OINDPs. In practice, the tamping pin method is mainly employed for filling hard-gelatin capsules intended for oral use. These capsule-filling machines are indeed unsuitable for micro-dosing. Yet this limitation is not inherent to the dosing principle itself; the error arises from failing to distinguish between a principle and its implementation.

For crystalline powders, the RSD is typically 2% or less. Cohesive powders are somewhat more challenging, but deviations generally do not exceed 3%. The accuracy also depends to some extent on the operator’s skill. The new electrically actuated SAK-1 eliminates this human factor, ensuring even more consistent results. Overall, the dosing accuracy of Miccados devices is more than sufficient and fully comparable to that of other laboratory dosing systems.

The critical parameter is that powder dosed with the SAK-1 attains a bulk density equivalent to that achieved with a drum filler. Moreover, the SAK-1 is capable of simulating specific operating parameters of a drum filler, such as differential pressure. Although complete equivalence can never be obtained, extensive experimental data demonstrate that the differences between powders dosed by the respective systems are negligible, and established methodologies are available to ensure comparability.

Yes, that is precisely their purpose. In the early stages of development, flexibility is far more important than throughput, since only small quantities are typically required. Miccados devices are specifically tailored to the requirements characteristic of these early development phases. Small laboratory machines, however, are ultimately only devices, too, as they are no longer fully automated. At the same time, they retain all the disadvantages of machines, such as costly format parts, complex operation, and the need for large amounts of powder to initiate the process. For this reason, they are of limited suitability for development work, even though they are often employed to facilitate a smooth transition to larger-scale equipment. Miccados devices bridge this gap by providing developers with exactly the tools they need, while at the same time ensuring reliable and seamless upscaling.

Two parameters are relevant: the dosing volume and the density of the dosed powder. For OINDPs, powder density is the critical factor. As a guideline for compaction, a pressure of approximately 4 g/mm² can be applied; (the corresponding information is printed on the dosing discs). The procedure is straightforward: a few dosing operations are carried out with an arbitrary dosing volume and the desired compaction pressure. The powder density is then determined by weighing, from which the required dosing volume can be calculated. This process is simple and can be completed within a few minutes.

Miccados devices are designed to make life in development labs easier. They are flexible, intuitive to use, cost-effective, and require virtually no maintenance. Unlike conventional micro-dosing machines, they are lightweight, portable, and need very little space – you can even set them up right next to your balance within minutes. They are ready to run within minutes and can dose, fill, and close containers in one step. The devices adapt easily to a wide range of formats, from all sizes of hard-gelatin capsules (including size 9/Torpac) to APTAR UDS cartridges. Training is simple – even new users are proficient after just a few hours. Another decisive advantage: very little surplus powder is needed, and almost no powder is lost during dosing. With a fully equipped SAK-1, developers can handle virtually any task quickly and efficiently – unlocking possibilities that standard lab machines simply cannot offer.

The output depends on several factors, but overall throughput is of secondary importance, as the SAK-1 is primarily intended for small-scale production. A critical consideration is whether each unit is weighed individually. In such cases, weighing—particularly when using a high-precision balance—takes considerably longer than the filling step itself. Without weighing, more than 50 capsules per hour can be filled without difficulty. In typical applications, the number of units processed ranges from a few dozen to several hundred. There are also documented cases where several thousand units were produced with the SAK-1, although this required additional time and patience. However there was no alternative due to delays in obtaining format parts for conventional dosing machines. For higher throughput requirements (approx. 3,000–5,000 units per day with two operators), the SAK-4 model was specifically developed.

Yes. Both the manual and the electrically actuated versions of the SAK-1 can be conveniently operated inside an isolator due to their compact dimensions. The electrically actuated model is powered by an integrated power bank, eliminating the need for external cables within the isolator. The main limiting factor is the handling of small containers with gloves, which may require some specific preparations, training and dexterity. Cleaning is straightforward, and cleaning validation can be avoided by using dedicated format parts for each potent compound.

The story is simple. While working in the pharmaceutical industry, I was responsible for developing a dry powder inhaler. In the beginning, powders were weighed by hand—an extremely frustrating process. Later, a small drum filler was used, but that was hardly better: some customers could not supply enough material (for example, a freeze-dried hormone), the required dosing volumes were expensive and slow to obtain, and scheduling trials with machine manufacturers was inflexible and time-consuming. In short, it was complicated, slow, and costly. That experience convinced me to build a device that solved these problems once and for all. The first prototype worked so well that, after leaving the company, I founded Miccados to make this technology available to others.

Simple: Miccados will provide you with a device tailored to your needs for a trial period of several months – free of charge. We deliver it to your site, set it up, and give you hands-on training. You only cover travel, accommodation, and incidental expenses. After the trial, you can return the device with no questions asked (return shipping at your cost). If you’d like to keep it, you can choose to rent or buy – and if you rent first, part of the rental fee will be credited towards your purchase. In addition, Miccados also offers to carry out filling trials directly at the customer’s site as a service, without the customer having to operate the device themselves – a true “fire-and-forget” option.

The standard delivery set of the SAK-1 includes 10 dosing volumes. In total, approximately 60 dosing discs are currently available and are generally in stock. If additional discs are required, the typical delivery time is the postal lead time plus 1–2 working days. The dosing range extends from 1.6 mm³ to 130 mm³. Each subsequent disc provides an increase of 10% in volume, which means that the volume doubles approximately every seven discs. This design ensures that the available dosing volume deviates by no more than 5% from the target value. Fine adjustment of the average dosed mass can be achieved via compaction parameters. It is recommended to order all potentially required dosing volumes together with the device, as the question is typically not if a certain dosing volume will be needed, but rather when. For one-off, non-recurring projects, dosing discs can also be borrowed directly from Miccados; this service is free of charge for existing customers.

Easy: choose the smaller disc and compact a bit more—or the larger disc and compact a bit less. You fine-tune with:

• Compaction force: adjustable in 1-g steps.
• Descent speed: faster → more mass; slower → less.

On the manual SAK-1 you set this via the handwheel; on the electric SAK-1 via a dial—perfect for quick, precise tuning of the average dose. A short check run (a few fills per setting) gets you on target within minutes.

The original mechanical SAK-1 was developed with the ambition of creating the simplest possible micro-dosing device. It operates purely mechanically, without the need for auxiliary media such as electricity or compressed air. Due to its robust construction, it is virtually indestructible (although it is not recommended to run a steamroller over it, as this could damage the steamroller). The device can remain unused for months and still be immediately operational. The mechanical version is particularly suited for non-GMP environments, where conditions may be less controlled.

The electrical version incorporates several additional features. The descent of the tamping pin is controlled by an electric motor, ensuring reproducibility and eliminating the human factor, thereby reducing variability between doses. Once parameters are set, consistent results are achieved regardless of operator. Descent speed of the tamping pin can be finely adjusted via a rotary dial, and integrated sensors monitor device status and prevent handling errors. This version is therefore the preferred choice when larger quantities are required. Documentation is also facilitated, as device parameters are clearly defined, making validation straightforward. Consequently, the electrical variant is particularly suitable for GMP-regulated applications, such as the manufacture of clinical trial samples. The trade-off is that it requires electrical power (24 V, supplied by a removable power bank) as well as a controller board and software, which make qualification and operation somewhat more complex.