Hard Gelatine Capsules Manufacturing

Quality control

for the manufacture of hard capsules

The process of manufacturing hard capsules is subject to very strict quality control at every stage of the process:

Selection and quality verification of raw materials for production

The completeness and consistency of the documentation shall be verified and each raw material shall be assessed in accordance with the analysis plan.

Weighing

The process of weighing the ingredients is carried out in accordance with an approved technological specification that assigns an individual code to each substance in order to ensure full traceability.

Mixing

Detailed operating instructions define the order and method of mixing all the ingredients. The operator makes an organoleptic assessment of the mixture - colour, smell, taste.

Encapsulation

The encapsulation process is based on the automatic closing of the obtained homogeneous mixture in the casing. The mixture is subjected to the process of encapsulation by means of an automatic capsule machine with a system of positioning and automatic opening of hard capsules. During the encapsulation process, identical portions of the mixture are closed in hard capsules by means of an appropriate size of the capsule format - depending on the needs we have sizes 1, 0, 00, 000. The capsule machine automatically closes the capsules and rejects incorrect capsules. Filled capsules are polished and dedusted by means of a horizontal polisher. The capsules are also passed through a metal detector.

Packing

If necessary, raw materials are subjected to a weighing process prior to the manufacture of hard capsules. The process is completed with a calibration using sieves, ensuring the granules are of the desired particle size

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Production process steps

Weighing

Mixing

We operate BIN mixers as well as "V" type mixers. In large scale production we mix batches with batch sizes up to 220kg. We have 8 high capacity BINs, which allows us to handle several production processes at the same time, without having to take into account changeover time.We validate the mixing processes and prepare dedicated instructions for each manufactured product, described in the product manufacturing technology.

Capsulation

We have the capacity to manufacture up to 45,000 capsules per hour. Currently, our facilities allow us to manufacture hard capsules in sizes 1, 0, 00, 000.

We cooperate with leading capsule suppliers, which enables us to provide fast turnaround times and ensure high product quality.

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We work with coatings :

gelatine,
made of HPMC (vegan),
we are fully aware of the possibilities of titanium dioxide (TiO2)-free

We can advise you on the right colour, depending on the batch colour and your marketing objectives.

In our technological park we have an automatic capsule machine, which handles high volume campaigns as well as a semi-automatic one, dedicated to shorter campaigns and more technologically advanced formulations.

Packaging

The capsules can be supplied as: bulk (BULK), blister, blister and carton, glass jar, plastic jar with label, pouch.
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We have high-performance blistering lines with automatic cartoners and automatic counters for packing into jars or pouches.
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Our packing plant is also suitable for unconventional orders where products are packed manually.

Questions for the hard capsule production service

Is it possible to encapsulate in bicolor capsule form?

Depending on customer needs, we can make hard capsules transparent, colored or two-color.

Are the capsule shells free of titanium dioxide (TiO2)?

Currently, white titanium dioxide-free areolae are available on the market. These coatings, as opposed to those with TiO2, are translucent/transparent. This means that their selection should also take into account the color of the charge, because in case of dark colored formulations the final visual effect may differ from expectations. We can offer packing in opaque capsules colored with iron oxides (black, green, yellow, red).

Do you manufacture hard capsule products according to 'clean label'?

We produce hard capsules free of excipients or with excipients, which allow to maintain the so-called "clean label". Each time a technologist evaluates technological composition of a product, on the basis of which we make an appropriate recommendation.

Do you produce products for vegetarians/vegans?

Yes, when products are made for vegans, we use cellulose-based, HPMC-based, cellulose-envelopes. These shells can be used by vegans.

What capsule sizes do you produce?

We have the ability to manufacture capsule sizes 1, 0, 00 and 000. The capsule size is selected by our team of experienced technologists based on the specific charge to be placed in the capsule.

I have my own raw material. Can you encapsulate it?

Yes. The procedure involves testing your raw materials for microbiological contamination, heavy metals and possibly other tests. If the raw material meets all the requirements set by our quality department, there is no obstacle to its being encapsulated by us. All the above mentioned activities are to ensure that the finished product is of the highest quality.