Considerations in determination of residual moisture in lyophilized demineralized bone matrix: the role of residual mois
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Considerations in determination of residual moisture in lyophilized demineralized bone matrix: the role of residual moisture analyzers Alexander H. Gage • Alan P. MacKenzie Daniel Baker • Helen E. Newman
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Received: 10 March 2012 / Accepted: 23 May 2012 / Published online: 9 August 2012 Springer Science+Business Media B.V. 2012
Abstract The objective of this study is to determine whether a residual moisture analyzer (RMA) can be an acceptable instrument for measuring the residual moisture in lyophilized demineralized bone matrix (DBM). Instruments from two different manufacturers with differing configurations and controls were compared: the Ohaus MB45 and Arizona Instrument MAX4000XL. The effects of various factors such as test temperature, drying profile, end point criteria, lift compensation, chamber configuration, and rehydration on residual moisture (RM) are examined. The performance of the RMAs is based on their ability to reproduce RM results obtained by the current standard gravimetric method. RMAs provide reliable, accurate and reproducible results in a number of industries that rely on the determination of RM. We hypothesize that RMAs are suitable for measuring RM in
A. H. Gage D. Baker H. E. Newman (&) Veterinary Transplant Services, Inc., 215 E Titus Street, Kent, WA 98032, USA e-mail: [email protected] URL: www.vtsonline.com A. H. Gage e-mail: [email protected] URL: www.vtsonline.com D. Baker e-mail: [email protected] URL: www.vtsonline.com A. P. MacKenzie Mercer Island, WA 98040, USA e-mail: [email protected]
DBM and provide validation study data with optimized settings for these two instruments. Potentially, such studies will provide justification for allowance of this methodology as an acceptable alternative to the current gravimetric method allowed by American Association of Tissue Banks Standards. Keywords Residual moisture Lyophilized Thermogravimetric DBM Freeze dried Gravimetric Abbreviations AATB American Association of Tissue Banks AZI Arizona Instrument DBM Demineralized bone matrix FDA Food and Drug Administration G Gravimetric GMP Good manufacturing practice KF Karl Fischer titration LC Lift compensation NMR Nuclear magnetic resonance spectrometry RM Residual moisture RMA Residual moisture analyzer TG Thermogravimetic
Background and introduction Tissue banks procure, process, package and distribute many freeze dried bone graft products and the American Association of Tissue Banks (AATB) Standards,
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Section E1.065, states that ‘‘residual moisture analysis shall not exceed 6 % of initial weight by gravimetric or Karl Fischer analysis, or 8 % by nuclear magnetic resonance spectrometry’’ (AATB 2008). Because this is a specified standard, each lot of lyophilized tissue must be tested, using one of the specified methods, for residual moisture (RM) and the results documented prior to lot release. Many tissue banks outsource this testing to labs and wait days–weeks for results. In this study we look at the current methods to measure RM for musculoske
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