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

Conclusion

The presentation order of the coupons appears to have no effect on the determination of VRLs. Both a sequential presentation from high to low concentration and a random presentation resulted in the same conclusions for VRL levels, thus confirming the ruggedness of the VRL determination.

Richard Forsyth is a senior consultant with Hyde Engineering + Consulting, 6260 Lookout Rd., Suite 120, Boulder, CO 80301, tel. 303.530.4526, fax 303.581.0839,
.

Submitted: Oct. 1, 2010. Accepted: Dec. 1, 2010.

References

1. R.J. Forsyth and V. Van Nostrand, Pharm. Technol. 28 (10), 58–72 (2004).

2. R.J. Forsyth and V. Van Nostrand, Pharm. Technol. 29 (10), 152–161 (2005).

3. R.J. Forsyth and V. Van Nostrand, Pharm. Technol. 29 (4), 134–140 (2005).

4. R.J. Forsyth, J.L. Hartman, and V. Van Nostrand, Pharm. Technol. 31 (4), 134–140 (2007).

5. R.J. Forsyth et al., Pharm. Technol. 30 (11), 90–100 (2006).

6. R.J. Forsyth, Pharm. Technol. 33 (3), 102–111 (2009).


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