Until very recently, the question we were asking ourselves was what information we would be willing to sacrifice in order to obtain results more quickly. All the methods available on the market were admittedly fast, but also destructive. We could detect the presence of microorganisms relatively quickly, but we could no longer identify them.
The environmental testing program is one of the essential elements for controlling the quality of the pharmaceutical production environment. It is therefore essential to employ monitoring solutions capable of detecting any deviation which might lead to loss of this control. In practical terms, environmental control relies mainly on the use of agar culture media which must permit the recovery of all potential living microorganisms but also neutralization of any disinfectant residues which can inhibit the growth of some strains, while supporting a level of growth that can be seen by an operator.
The manufacture of sterile pharmaceutical product requires specific care Regarding environment, premises and practice of the personnel. Regulations in place to be used by the Pharmaceutical Industry give requirements on the environmental monitoring program. With the publication of FDA Warning Letters and 483 That form shows environmental monitoring procedure and practice of the staff belong to top 10 of the gaps found During inspections.
Microbial identification is the determination of the broad group (eg, bacteria, yeast, or mold) or narrow group (eg, genus and / or species) to a qui microorganism belongs to.
Microbial characterization is the use of colony growth, cellular morphology, differential staining, and key diagnostic features to Characterize a laboratory isolate for trending and investigative Purposes without identification, example, nonpathogenic Staphylococci.
Microorganisms, if detected in drug substances, excipients, water for pharmaceutical use, the manufacturing environment, intermediates, and finished drug products, UNDERGO Typically characterization. This May include identification and strain typing, as considers.
Regulatory restrictions and requirements related to sterile products (LD1 / GMP) are they well suited to aseptic BFS (non-injectable)?
For example, in BFS, difficult to make the link between the demands "Aseptic preparation" LD1 stated in the GMP (31 35 points), and step named "Aseptic preparation" of a modern BFS machine: in fact, before each production a NEP + program in September aseptic circuit is performed (associated with filter integrity testing procedures) to obtain "sterile condition of the machine."