Recontamination of food products can cause foodborne illnesses or spoilage of foods. It is
therefore useful to quantify this recontamination so that it can be incorporated in …

Ophthalmic preparations are sterile liquid, semi-solid, or solid preparations intended for
application to the conjunctiva, the conjunctival sac, or the eyelids. Sterility is a key issue in …

Written by an expert in the industry, this text addresses the specifics of contamination,
including particle origination, characterization, identification, and elimination, with a special …

This paper describes the fundamental mechanisms of microbial contamination during
manufacture of pharmaceutical products. Models are derived that describe air and surface …

The microbial risk to aseptically manufactured products in pharmaceutical cleanrooms can
be assessed by the use of fundamental equations that model the dispersion, transfer and …

Analytical methods for hazard and risk analysis are being considered for controlling
contamination in pharmaceutical cleanrooms. The most suitable method appears to be the …

For therapeutics administered by certain routes such as pulmonary delivery, plastic ampuls
can offer many advantages over glass ampuls, vials, or syringes. Plastic ampuls are …

This reference surveys emerging trends, concepts, and procedures used in the
characterization and control of contaminants; the sterile production of traditional drugs and …

The microbial risk to patients from aseptically manufactured pharmaceuticals is dependent
on the chance that a product contains sufficient microbes to initiate an infection. This …

Regulatory authorities set requirements on factors such as maximum allowed airborne
particle concentrations in critical areas and the surrounded environment. An important issue …