The expansion, which involved the addition of a third sterilization unit, was designed to meet growing demand from its customers for “clean, organic sterilization”, said BI.
The company’s proprietary steam sterilization process Protexx HP system uses super-heated dry steam to reduce microbiological load in raw materials. BI said this yields results comparable to treating ingredients with ethylene oxide or irradiation, “but without the potential regulatory issues”.
GMP compliant
It claims its system is the industry’s only species-specific, organic steam sterilization method. The high-heat, low-moisture process is compliant with new current GMP regulations, said the company.
The new unit will be installed at BI’s headquarters in Long Beach, California, which already house the firm’s first unit. A third unit is located at BI’s processing facility in Suzhou, China.
The company, which has been using this sterilization process for around six years, said it has over 700 species and genius specific computer protocols to sterilize its botanical ingredients.
These controls allow it to sterilize its ingredients without affecting volatile oils and color integrity, it said.
Irradiation concerns
Steam sterilizing provides an alternative to irradiation, which is not a globally accepted method, and which is also subject to consumer concerns.
The irradiation process exposes foods to ionizing radiation that kills insects, moulds, and up to 99 per cent of pathogens. Although upheld by many as a safe process, the regulatory story on irradiation is inconsistent across the globe.
This has meant that herbal extractors who want to market their wares on an international basis are seeking other ways to guarantee quality and safety.
In comment 292 to FDA’s preamble to the final cGMP ruling for dietary supplements, the agency writes: “We are not adding ‘irradiating’ to the list of practices [to prevent the growth of microorganisms] because, at this time, irradiation of dietary ingredients and dietary supplements, as a means to reduce or eliminate microbial loads, is not permitted.” Click here to access the full comment.
"The FDA's ban on sterilizing raw materials with ethylene oxide and irradiation, as well as the phasing in of the new cGMP's, has created an increased demand for BI's proprietary steam sterilization services," said George Pontiakos, president and CEO of BI Nutraceuticals.
"With the addition of a third steam sterilization unit, BI can more effectively meet the demand for our steam sterilized botanical ingredients, as well as offer our customers in the food industry toll sterilization services for food ingredients and spices."