Table 1. Requirements for allergen products / applicable tests according to the monographs of the European Pharmacopoeia, depending on the allergen source (selection according to a needs survey carried out amongst statutory accident insurance institutions, see article by Raulf & Kespohl in part 1 of the special issue [9]).
| Allergen source | Requirements for the source material according to the monograph (Ph. Eur.) | Requirements for the final product according to the monograph (Ph. Eur.) |
| Wheat (flour, grain) | “Allergen products (01/2022:1063)” – Obtained from qualified suppliers – Defined, where possible, by their origin, nature, method of collection or production, and pretreatment – Establishment of control methods and acceptance criteria relating to identity and purity – Storage under controlled conditions, justified by stability data; ensuring a consistent composition from batch to batch – When applicable, pesticides, heavy metals, and residual solvents are limited – Microbial contamination should be monitored – For foods: suitable quality for human consumption, the origin, and the processing stage is stated |
“Allergen products (01/2022:1063)” Protein content (80 – 120% of the stated content) – Protein profile (corresponds to that of the in-house reference preparation) – Water/loss on drying (for freeze-dried products) – Sterility (parenteral preparations, eye preparations, preparations for inhalation or preparations for skin testing) – Microbial contamination (for non-sterile allergen products) |
| Rye (flour, grain) | ||
| α-amylase | ||
| Glucoamylase | ||
| Spruce wood | ||
| Beech wood | ||
| Latex | ||
| Phytase | ||
| Fish (cod/salmon) and a freshwater fish | ||
| Shellfish (shrimp) | ||
| Lepidoglyphus destructor | “Mites for allergen products (01/2017:2625)” In addition to the monograph “Allergen products” – Foreign matter, defined as any particles that are not part of the mite culture; detected using a suitable microscopic method, with a limit based on historical data – Water / loss on drying (for dried material) – Purity (when the source material is a purified fraction of the mite culture) |
|
| Tyrophagus putrescentiae | ||
| Acarus siro | ||
| Cattle hair/epithelia | “Animal epithelia and outgrowths for allergen products (01/2017:2621)” In addition to the monograph “Allergen products” – Foreign matter, defined as vermin (e.g., mites and fleas), dirt, and foreign animal epithelia and outgrowths; determination by microscopic examination, ELISA, visual inspection and/or tactile inspection, must be below a predefined and justified limit – Water/loss on drying (for dried material) |
|
| Mouse hair/urine | ||
| Rat hair/urine | ||
| Aspergillus fumigatus | “Moulds for allergen products (01/2017:2626)” In addition to the monograph “Allergen products” – Foreign species, their absence is determined by macroscopic and microscopic examination – Water/loss on drying (for dried material) – Mycotoxins, their content is determined |
|
| Penicillium chrysogenum | ||
| Mold (as a moisture indicator, e.g., Aspergillus versicolor) | ||
| Stachybotris chartarum |