The Bugs Don't Lie
JP Agalloco - PDA Journal of Pharmaceutical Science and …, 2019 - journal.pda.org
Sterilization is a critical process in the preparation of many drug products. Its execution and
validation are addressed in numerous regulatory, pharmacopeial, and industry documents …
validation are addressed in numerous regulatory, pharmacopeial, and industry documents …
[BOOK][B] Handbook of Validation in Pharmaceutical Processes
J Agalloco, P DeSantis, A Grilli, A Pavell - 2021 - books.google.com
Revised to reflect significant advances in pharmaceutical production and regulatory
expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition …
expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition …
[PDF][PDF] Alternative technologies for sterility testing
A Meszaros - Rapid Microbiological Methods in the …, 2003 - library.navoiy-uni.uz
The use of compendial standards for the regulation of the identity, purity, potency, quality,
packaging, labeling, and storage of parenteral drugs is familiar. Among the attributes that …
packaging, labeling, and storage of parenteral drugs is familiar. Among the attributes that …
[HTML][HTML] Achieving Balance in Sterile Product Manufacturing
J Akers, JP Agalloco - Pharmaceutical Technology, 2015 - pharmtech.com
AbstractValidating sterile product manufacturing processes requires the use of biological
indicators to demonstrate the lethality of sterilization techniques. The indicator organisms …
indicators to demonstrate the lethality of sterilization techniques. The indicator organisms …
Achieving sterility in biomedical and pharmaceutical products (part-I): thermal, chemical, and filtration sterilization
Sterilization is of utmost importance in the medical device and health-care industries, as
failure to adequately remove microorganisms, including bacterial spores, from reusable …
failure to adequately remove microorganisms, including bacterial spores, from reusable …
Sterilization of pharmaceuticals: technology, equipment, and validation
Sterilization of pharmaceutical preparations intended for either parenteral, ocular,
implantation, or any specific use is a mandatory clinical and regulatory requirement. Any …
implantation, or any specific use is a mandatory clinical and regulatory requirement. Any …
The evolving USP sterility test
MS Cooper - PDA Journal of Pharmaceutical Science and …, 1982 - journal.pda.org
The USP chapter titled “Sterility Tests” will be almost completely rewritten in USP XXI. Drafts
for comment will shortly appear in Pharmacopeial Forum and USP Comment Proofs.“Sterility …
for comment will shortly appear in Pharmacopeial Forum and USP Comment Proofs.“Sterility …
Sterilization validation
MJ Akers, NR Anderson - Pharmaceutical Process Validation, 2003 - taylorfrancis.com
Sterile products have several unique dosage form properties, such as freedom from micro-
organisms, freedom from pyrogens, freedom from particulates, and extremely high standards …
organisms, freedom from pyrogens, freedom from particulates, and extremely high standards …
[BOOK][B] Sterility, sterilisation and sterility assurance for pharmaceuticals
T Sandle, Sandle - 2013 - Elsevier
This chapter provides an introduction to the main themes of this book. It examines the theory
of sterility and how it is a concept of probability. Microorganisms and viability in relation to …
of sterility and how it is a concept of probability. Microorganisms and viability in relation to …
[PDF][PDF] Quality-control analytical methods: The quality of sterility testing
TC Kupiec - International Journal of Pharmaceutical Compounding, 2007 - arlok.com
Microbiology, like compounding, is a science that must be demonstrated to show that it is
reliable, reproducible, and scientifically sound. Aseptic technique must become second …
reliable, reproducible, and scientifically sound. Aseptic technique must become second …