Industry solutions Medicinal herbs

Regulatory non-irradiated. Pharmaceutically pure. Secure the decisive market advantage for yourself: as we work with vacuum saturated steam instead of gamma radiation, your product is considered non-irradiated for regulatory purposes. This means: no AMRadV labeling requirement and maximum acceptance by doctors and patients.

• Active ingredient guarantee: Full preservation of cannabinoids and terpenes. The sensitive active ingredient profile and the entourage effect remain stable
• Compliance: Full conformity with the microbiological limits of the BfArM and Ph. Eur.
• No irradiation: No ionizing radiation – protects the molecular structure of the flower and is sustainable
• Scalability: Efficient processing from 50 kg to 5,000 kg in just 1-5 working days

Precision and experience for the phytopharmaceutical industry. Leading pharmaceutical manufacturers have relied on our expertise in microbiological refinement for over three decades. We guarantee compliance with Ph. Eur. Limits for over 87 validated materials.

• Full-service processing: We combine sterilization with specialist services such as GMP-compliant grinding and homogenization.</li
• Validated processes: Safety thanks to over 30 years of experience and process validation in accordance with EU GMP Annex 15.
• Protection of active ingredients: The BIOSTERIL® process protects essential oils and secondary plant substances through precise temperature control in a vacuum.
• Application areas: Ideal raw material base for medicinal teas and preparations in gynecology, rheumatology and gastroenterology.

The last-minute solution when limits are exceeded. When imported batches or outdoor harvests exceed the limits for mold, yeast or bacteria, time is of the essence. KPS acts as your safety net for out-of-spec findings.

• 24-48h turnaround: Rapid intervention to avoid delivery delays and penalties
• Pathogen elimination: Safe elimination of yeasts and moulds while maintaining the visual product quality (shelf appeal).
• Asset Protection: Saving high-quality raw materials and minimizing total economic loss
• Laboratory Support: Close cooperation with accredited laboratories for rapid analytical re-release.

No. This is one of the greatest strategic advantages for our customers. As BIOSTERIL® is a purely physical vacuum saturated steam process and does not use ionizing radiation (gamma/e-beam), it is not subject to the German Drug Irradiation Ordinance (AMRadV). Your goods are considered non-irradiated and do not require any corresponding labeling or complex special approvals for the distributor.

No. The fear that the goods will get “wet” is unfounded with our process. The saturated steam only acts on the surface for a fraction of a second in a vacuum. The immediate evacuation (suction) of the steam means that the moisture inside the flower remains unaffected. The product leaves the system with virtually unchanged residual moisture – exactly as it was delivered.

The BIOSTERIL® process was specially developed for thermolabile (heat-sensitive) substances. By working in a vacuum, we can precisely control the sterilization temperatures and keep the reaction time extremely short. Analyses regularly confirm that the full spectrum of cannabinoids and the sensitive terpene profile remain stable. The character (shelf-appeal) and the “entourage effect” of your medicinal herbs or cannabis flowers are retained.

KPS is a declared quality leader. We have a manufacturing authorization according to § 13 AMG and work strictly according to EU-GMP standards. The BIOSTERIL® process is fully validated in accordance with EU GMP Annex 15. Each batch is reproducibly documented, so that you have maximum security for your quality assurance (QA) and audits.

Yes – under the right conditions. The reactive use of BIOSTERIL® for a batch showing abnormalities is possible, but requires a comprehensive risk assessment, stability data and batch-specific process validation. Our resources are available on a flexible basis to partners with the relevant documentation.

Our recommendation remains the same: to incorporate BIOSTERIL® preventively as a fixed step in the manufacturing process – this is more compliant from a regulatory perspective, more commercially viable and simpler in terms of documentation.

Definitely yes. While gamma irradiation is based on radioactive sources (Cobalt-60), BIOSTERIL® only uses pure water and energy. There is no radioactive waste, no chemical residues and no ionizing radiation is released into the environment. This makes KPS the ideal partner for companies with high ESG and sustainability standards.

KPS offers maximum scalability for the pharmaceutical industry. We treat specialized niche batches from 50 kg just as reliably as large industrial quantities of up to 5,000 kg. Regardless of the quantity, we guarantee a germ reduction of up to 99.9% with consistent active ingredient quality.

Yes, Kündig Pharmaceutical Solutions is a full-service hub. In addition to sterilization, we offer GMP-compliant grinding to your desired cut size and homogenization of batches. This ensures a standardized distribution of active ingredients across the entire batch – ideal for medicinal teas and extracts.

The path to market release is modular and efficiently structured at KPS:

1. Specification: We check your CoA values and reserve your GMP production slot
2. Configuration: You select the required services (sterilization, grinding, drying).
3. Refinement: The validated treatment takes place under strict EU GMP monitoring
4. Release: You receive the processed goods back including complete GMP documentation for immediate market entry.