USP〈1120〉 ENSURING MICROBIOLOGICAL QUALITY OF ARTICLES OF BOTANICAL ORIGIN

INTRODUCTION

This general chapter provides information on practices to prevent as well as methods to treat microbial contamination of articles of botanical origin. General chapter Manufacturing Practices for Dietary Ingredients 〈2740〉 defines contamination as “The undesired introduction of a substance of a biological (including allergenic), chemical (including radiological), or microbiological nature, or foreign matter, into or onto a raw material, another ingredient, in-process material, or dietary ingredient during production, sampling, packaging, repackaging, storage or transport”. The information is not limited by the regulatory framework in that microbiological quality is relevant to articles of botanical origin, whether such materials are components of conventional food products, dietary supplement products, or over-the-counter (OTC) drug products.

Compliance with current Good Manufacturing Practices (cGMPs) requires the control and prevention of microbiological contamination of botanical raw materials, processed ingredients, and finished products [see 21 CFR §111 and 21 CFR §117 (1–2)] and the regulation on foreign supplier verification programs (FSVPs) for importers (3). Raw materials must not contain levels of undesirable microorganisms, i.e., environmental pathogens such as Salmonella spp., that would cause the product to be adulterated, or the material must be pasteurized or otherwise treated [see 21 CFR §117.80— Processes and controls. (b) Raw materials and other ingredients]. The US Food and Drug Administration (FDA) defines an environmental pathogen as “a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen.” Examples include Listeria monocytogenes and Salmonella spp. but not the spores of pathogenic spore-forming bacteria (see 21 CFR §1.500—What definitions apply to this subpart?).

The sources of microorganisms on or in dried botanicals comprise, on the one hand, the natural microflora of living plants [both surficial and endophytic (commensal or symbiotic) fungi and bacteria] and, on the other hand, contamination occurring during cultivation, harvest or postharvest handling, and manufacturing and processing activities (4). With regard to the natural microbial flora, the presence of microorganisms in dried botanicals does not necessarily mean that the materials are contaminated or objectionable, given that intended use is critical in making this determination (5). Intrinsic factors that can determine the microbiological quality of botanicals include:

The nature of the plant and its natural barriers (e.g., resins or waxy suberin deposits).

Structure of the plant (e.g., a protective bark or cuticle).

Plant composition (e.g., naturally occurring antimicrobial compounds such as volatile oils).

Extrinsic factors include:

Climate

Humidity (favorable for fungal contamination)

Location

Irrigation (water with animal fecal contamination)

Fertilization (application of organic fertilizers)

Method of harvest (hand harvest or machine harvest; cleanliness of equipment)

Postharvest handling and transport

Physical state of the herbal material (whole or cut)

Technological treatments (extent of drying and remaining water activity, sorting, cutting, sifting)

Packaging and storage conditions

Sources of exogenous microbial contamination (e.g., insects, rodents, or inadequately filtered ventilation) (6–7)

Microbial contamination with environmental pathogens generally occurs as spot contamination. Regardless of the sampling plan used, it is statistically nearly impossible to confirm the absence of Salmonella in a batch of botanical raw materials due to a lack of homogeneity in dispersal within the material (8). However, there is a higher likelihood of detecting contamination in processed ingredients, for example, following sifting, particle sizing, and blending.

Source from FDA

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