Production process
Made in Bulgaria, from A to Z
Strain production
The probiotic strains for Lactoflor come from the Lactina factory in Bankya - our own production facility for starter cultures and probiotic strains. There, we work with a specialist who has dedicated his life to the field and previously managed the state dairy company.
The strains are isolated from natural sources in Bulgaria: Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus lactis, Lactobacillus bulgaricus, Streptococcus thermophilus, and others.
They are all deposited under patent protection at the National Bank for Industrial Microorganisms and Cell Cultures. From there, they begin their journey through the production process - and the first condition is temperature.
The five stages at the Lactina factory
Every batch starts here, before the strains embark on the cold chain.
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Preparatory stage
Reconstitution of dry substances and preparation of liquid culture medium for microorganism growth.
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Fermentation
In the automated bioreactor system, several production stages take place, namely: sterilization, inoculation, fermentation, enrichment, and cooling.
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Pelletization
Used in the production of frozen starter cultures.
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Freeze-drying
The liquid mass is being dried.
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Grinding, mixing and packaging
The ready-made dry products are ground, mixed if necessary, and packaged according to the client's requirements.
Cold chain
Fundamental is the method of production, or the so-called cold-chain technology, which is used for Lactoflor products.
Once isolated, the probiotics are lyophilized and only then sent for blending and packaging. Until the moment of packaging, they must be stored at the correct temperature.
That is why we ensure constant and strict logistics management of the cold chain throughout the entire delivery process. Probiotics have a short, specific time frame of permissible deviation – the time during which the products are not refrigerated and are in contact with air. This must be strictly observed, otherwise the probiotic microorganisms will die.
Any deviations outside of refrigerated storage are monitored and documented in detail through records in the main batch documentation. In all our production facilities, low humidity below 20% is maintained year-round to preserve and protect the probiotic products during the periods of deviation, blending, and packaging.
Lactoflor probiotics are transported and stored under temperature control at approximately -20 °С. They are then blended and packaged in production facilities with an average temperature of 2 °С to 8 °С. Alarm systems signal in the event of an unexpected temperature change.
DR capsule
Some Lactoflor products are filled in the acid-resistant Capsugel® DRcaps® capsule. It is plant-based, gelatin-free, and therefore also suitable for vegetarians.
The principle is delayed release, not enteric coating: the capsule is designed to break down more slowly in the stomach environment, so that the probiotic strains can continue further along the digestive tract - all without the need for a film coating.
The capsule also has improved stability against moisture and hygroscopic ingredients, which is important for lyophilized probiotic cultures.
The DR capsule is used in Lactoflor Opti6 (30 and 12 capsules) and Lactoflor BioPlus capsules.
Packing
The stable probiotic product is manufactured in heat- and moisture-resistant packaging that keeps the good bacteria protected from the environment, allowing them to reach the gastrointestinal tract alive.
The type of capsules used is important. DR capsules are specially designed to protect probiotic strains from stomach acids, ensuring the bacteria reach the intestines in their most active state.
Probiotics must be packaged with care. Exposure to air at any point during the production and packaging process will adversely affect their viability. If humidity and oxygen levels are not regulated, it will effectively lead to microbiological degradation.
We follow precise packaging processes and ensure a controlled production environment. At a certain point in the process, the probiotic products come into contact with air, which is why the air is filtered in a pharmaceutical-grade 100,000 cleanroom packaging environment. The air is always fresh and filtered to prevent any form of contamination.
Quality control
At Lactoflor, we believe that quality begins with the very first step. That is why we have our own laboratories where we carefully monitor every single stage.
All Lactoflor products are manufactured in Bulgaria in strict compliance with European safety and quality requirements - from the selection of raw materials and the development of formulas to production and packaging.
We operate according to established international standards such as GMP, ISO, and HACCP, which ensure that every product is created under strict control and full traceability.
Each batch undergoes laboratory tests to ensure that the products are pure, safe, and free from unwanted impurities such as heavy metals or contaminants. Deliveries are accompanied by guarantees of microbiological integrity and purity.
This allows us to confidently offer you reliable and effective products that you can trust - every day.
Certificates
GMP - quality assurance for every batch
The GMP certificate is a system of rules for the production of pharmaceutical products and food supplements. It certifies the proper implementation of the production process with the necessary high quality of the final product. The presence of this certificate guarantees that all elements and requirements in the production process have been met. The GMP certificate is a standard that emphasizes control throughout all stages of production:
- Request
- Raw material path
- Supplier quality systems
- Use of state-of-the-art technologies and high-tech equipment
- Precise control method
- Premises hygiene
- Water and air systems
- High qualification of the personnel employed in production
- Product distribution and withdrawal system
The purpose of the GMP certificate is to establish that the products from every single batch have the same quality as the others.
Certificate No. BG/GMP/2024/269
Issued by the Bulgarian Drug Agency to KENDY Ltd. for the manufacturing site at 8 Gurmazovsko Shose St., 2227 Bozhurishte.
The on-site inspection was carried out on 12.01.2024, the certificate was issued on 14.05.2024.