Table 2.

Manufacturing process parameters and in-process controls for the allergen source material.

Description	Control Parameters	Purpose
Process Parameters
Dry roasting conditions	Bed depth	Ensures 5-log reduction in pathogenic organisms (Salmonella), controls potency of allergens, protein profile, and physico-chemical attributes of peanut flour derived from the roasted peanut kernels
	Zone 1 temperature
	Zone 2 temperature
	Belt speed
Hydraulic press	Dwell time	Determines the fat content of the source material
In-process Controls
Color as measured by colorimeter	Ground peanut paste samples	Used to adjust roasting conditions to ensure source material has desired quality
	Source material (peanut flour)
In-line metal detection	Detection and removal of:	Ensure removal of ferrous and nonferrous metals from the source material
	Ferrous metals
	Nonferrous metals
	Stainless steel
Fat content by near-infrared measurement	Fat content	Used to adjust press dwell time to ensure final product has a desired residual fat content

The actual roasting conditions used to produce peanut flour vary based on the color requirements, the desired taste and aroma profiles of the peanut flour and peanut oil obtained from the roasting process. To ensure the consistent quality of peanut flour used for the manufacturing of Palforzia^®, only the batches of peanut flour that have been roasted under certain conditions are used. In addition, the color, the presence of metal particles, and the fat content of peanut flour are monitored during the manufacturing of peanut flour from raw shelled peanuts. The peanut flour meeting these requirements is selected for pre-screening, involving testing for attributes summarized in Table 1. Only those peanut flour lots that meet the pre-screen acceptance criteria are then available for extensive testing into drug substance.