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OIT-006 / 2.1

Microbiology, packaging and stability

Developing a justified use period for the exact allergenic matrix.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

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Procedure

  1. Define risks from raw material, water, equipment and handling. A food origin does not exclude microbial burden.
  2. Select suitable microbiological tests and criteria with an analytical partner for the product and use. Demonstrate preservative neutralisation in testing where needed.
  3. Study the exact packaging and repeated opening/withdrawal. Refrigeration and high sugar alone do not validate preservation.
  4. Combine microbiological evidence with chemical/physical stability, protein, redispersibility and delivery. One passing test does not establish the entire BUD.
  5. Assign a period and conditions only after reviewing all evidence. Do not transfer the period of another medicine or another nut.
  6. Define handling of temperature excursions, transport and opening. Do not give generic refreezing or reheating instructions without specific evidence.

Additional detail

Assess chemical/protein retention, physical stability, microbiological quality and preservative performance in intended use separately. EMA requests real-time studies and stability-indicating methods in its industrial scope; here those principles inform study design, not authorisation or a copied local protocol. PALFORZIA storage instructions do not establish pistachio-syrup BUD.

A general BUD category does not resolve OIT-matrix questions of uniformity, allergenic profile or delivered dose. The final period is the shortest of all supported quality/clinical constraints.

Stop criterion

Insufficient BUD evidence or unacceptable microbiology: do not supply.

Related forms

F-005, F-006

Sources and references

  1. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007; adopted 20 November 2008; effective 20 May 2009; remains current effective quality version on EMASections 2, 4.1.1, 4.2.4.4, 4.4.3–4.4.5; document pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-10-14
  2. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Recommendations 8, 9, 12 and 13; desensitisation versus remission/continued treatmentSpecialist clinical recommendations; not stability evidence for local syrups or suspensions2026-10-14
  3. FDA — PALFORZIA prescribing informationUS prescribing information, Revised 07/2024; rechecked 2026-10-14Sections 2.3, 4, 5, 11 and 16; current FDA-linked labelSpecific authorised product only; no equivalence with pharmacy-made peanut preparations2026-10-14
  4. NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-10-14
  5. EMA — Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populationsEMA/161669/2025; adopted 10 June 2025; effective 1 January 2026Sections 2, 4 and 4.1 (Type I allergy quality aspects); pp. 4–6; section 8.4 for food-allergy endpointsIndustrial allergen development and quality guidance; complements 2008 guideline. Section 4.2 Type IV patch-test exceptions are not transferred to food OIT.2026-10-14