Ruggedness of Visible-Residue Limits for Cleaning (Part II) - Pharmaceutical Technology

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Ruggedness of Visible-Residue Limits for Cleaning (Part II)
The author challenges current detection methodologies.


Pharmaceutical Technology
Volume 35, Issue 3, pp. 122-128


Table I: Residue target concentrations.
Determinations of VRLs consistently followed the same manner of presentation for the observers. The arrangement of the soiled coupons began with the ARL, which was the lower of either the health-based limit or the adulteration-based limit (4 g/cm2 ). Residue levels decreased sequentially with a solvent blank as the last sample. The observers viewed all of the sample soils as a single group. For the majority of samples (133 of 200 = 67%), the lowest spotted residue was visible for the observers. The VRL was reported as less than the lowest residue concentration. This report resulted in a refinement of the sample preparation. The updated residue preparation, as shown in Table I, targeted lower concentrations to determine the actual VRL and provide more accurate program data. With this refinement, the observers continued to visually detect the lowest residue limit in the majority of tested compounds.


Table II: Compound visible-residue limits (VRLs)
An alternative arrangement of the residue soils was considered to determine whether presenting the soiled coupons to the observers affected VRL determinations. This alternative arrangement consisted of a randomized presentation of several compounds at or near the determined VRL, including a number of blank coupons. The observers did not know beforehand the number of compounds tested or their concentrations, the number of soiled coupons, or the number of blanks in a 25 coupon array. A randomized coupon presentation is more scientifically justified and easier to defend.


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