从不锈钢优惠券 API 残留量低和可变的经济复苏所作的主要贡献被追溯到缺乏明确规程的优惠券表面清理。清洁表面的优惠券导致一致、 准确的加标的回收和重复性好的结果。从不锈钢优惠券回收率高的示威,从制造设备使用经过验证的方法获得的实际清洗验证结果应该是准确和精确,反光的设备上的残留水平以最低风险的假阴性率为可能危及病人安全的产品的结转。
其次?…
Declarações
The authors have nothing to disclose.
Acknowledgements
没有供资机构支持这项工作。
Materials
stainless steel coupons
GlobePharma (New Brunswick, NJ ).
SS316-20RA-50cm2
Clean in place solutions (CIP100 and CIP200)
were obtained from Steris Corporation (Mentor, OH)
1D10BG
Alkaline detergent and acid detergent, respectively
Positive displacement pipettes
Gilson (Middleton, WI).
HPLC grade water
Millipore Milli-Q Advantage Water Purification System (Darmstadt, Germany) or from Honeywell Burdick & Jackson (Muskegon, Michigan)
7732-18-5
HPLC grade Methanol
EMD
MX0475-1
glacial acetic acid
EMD
MAX0073P5
HPLC grade Acetonitrile
J.T. Baker (Avantor Performance Materials, Center Valley, PA)
75-05-8
Trifluoroacetic acid
J.T. Baker (Avantor Performance Materials, Center Valley, PA)
Haidar Ahmad, I. A., Blasko, A. Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface. J. Vis. Exp. (126), e56175, doi:10.3791/56175 (2017).