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OIT-004 / SOP v2.0

Controlled processing and protein recovery

Process development and control; no recipe, temperature or time is supplied as a validated setting.

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Procedure

  1. Document the process flow for the exact material and form: milling, wetting, mixing, heating, cooling, filtration and filling where applicable.
  2. Define critical parameters from study of the specific process. Previous experience at another strength does not demonstrate process equivalence.
  3. Measure actual product temperature, time and cooling conditions. Heating is not automatically sterilisation or allergen neutralisation.
  4. For filtration/sieving document material, size, retention and residue composition. Removing solids may alter the delivered protein.
  5. Relate input/output mass and volume to suitable analysis before and after critical stages. Total mass balance does not establish allergen balance.
  6. Approve operating ranges, sampling and criteria before routine use. Do not compensate for protein losses by arbitrarily adding raw material.

Edition-specific detail

Analyte recovery (%) = 100 × output analyte amount / input analyte amount, using the same analytical basis. Assess discarded filters/solids where needed for balance, including dilution and volume changes. Total mass balance does not guarantee allergenic-protein balance.

Stop criterion

Unknown recovery, uncontrolled heating or unassessed filtration changes: quarantine.

Related forms

F-002, F-009

Sources and references

  1. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007, 2008Sections 2, 4.1.1, 4.2.4, 4.3, 4.4.3–4.4.5; pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-09-12
  2. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Abstract and published guideline recommendations; DOI 10.1111/all.16345Specialist clinical recommendations; not stability evidence for local syrups or suspensions2026-09-12
  3. FDA — PALFORZIA prescribing informationUS prescribing information, July 2024 revision, accessed 2026-09-12Sections 1, 2.3, 4, 5 and 16Specific authorised product only; no equivalence with pharmacy-made peanut preparations2026-09-12
  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 revision2026-09-12