Ankur Choudhary Print Question Forum No comments Introduction of undesired dust or dirt into or on to during manufacturing, packing and transportation is called as contamination and contaminant is the unwanted element being introduced in the system. It is any substance which has an adverse effect on the product or process. Contamination is of three types depends on the mode by which they can damage.
It is protected by copyright and appears here with permission. Introduction The development of a microbial contamination control program is critical to the effort to get a new facility qualified, and to maintain the facility in a state of control once qualified.
The design and successful execution of a contamination control program requires a plan.
The creation of a specific document allows the company philosophy, goals, and expectations to be formalized and agreed to by all parties. It also provides the goals and metrics by which the state of control for the facility can be measured in the annual review.
This plan is important no matter what type of facility is being developed. Although it is most frequently used in the Quality plan for commissioning an aseptic facility, this is also important and should be used for commissioning and controlling facilities using terminal sterilization, and for non-sterile manufacturing facilities.
Why be concerned with contamination control in a nonsterile manufacturing facility?
In many ways contamination control is more of a concern in a non-sterile facility than in sterile product production facilities. The sterile production facility knows there is a problem with contamination and cross-contamination of batches, the non-sterile facility has a great temptation to belief they are not touched by these issues.
This can lead to an extremely cavalier attitude about contamination control by the operators and management. The non-sterile manufacturer is responsible for all aspects of his product, including any objectionable organisms present Sutton, as described in a recent newsletter PMF Newsletter v12 n7.
The API manufacturer is also concerned with contamination control. This essay will not be able to provide more than an overview of issues in the space available this month. However, it is hoped that the need for an adequate contamination control plan for a facility will be made clear, and the beginnings of the content of such a plan explained.
Scope The Contamination Control Plan should be developed as part of the facility commissioning effort. As such, there will be four distinct phases of the facility operations that will need to be addressed: Commissioning and initial start-up Shut-down for regular maintenance Start-up after scheduled shut-down These phases will not have the same level of contamination control.
In fact, the third and fourth phases may well have different levels of control to be addressed. A good plan will discuss the concerns specific to each of these phases.
This program, and the protocol governing the program, are essential documents useful in documenting the rationale and methods used to accomplish three tasks: Minimizing the bioburden throughout the manufacturing processes Minimizing the level of batch residual cross-over contamination Minimizing the level of cleaning material residual contamination As the SME Subject Matter Expert in microbiology, we will be most heavily involved in the first of these three tasks, minimizing bioburden.
However, all three will be discussed at least briefly in this essay for context. Minimizing Bioburden Validated methods All measures of bioburden in a facility will be indirect. We cannot count bacterial cells on a surface or in the air. We must transfer the microorganisms to an agar plate or some other mechanism and count colony forming units.
If we make the assumption that the transfer of microorganisms from the air or from a surface to agar is consistent, then we can use these numbers to estimate trends over time.However, tanks are often placed directly in hygienically sensitive environments and thus are subject to the cleaning procedures prevalent in pharmaceutical production.
Good Manufacturing Practice (GMP) puts great emphasis on the prevention of cross-contamination . • To minimise the risk of medical hazard due to cross-contamination, dedicated and self-contained facilities should be available for particular medicinal products e.g.
beta lactum products, antibiotics, hormones, cytotoxic, drugs manufactured from live microorganisms. Cross contamination can occur either by introduction of micro-organisms to the product or by other pharmaceutical products in the mixed plant manufacturing.
Studies showed that main contamination within pharmaceutical production occurs by people, air, equipment, water and or raw materials. The cGMP regulations do not strictly cover API (active pharmaceutical ingredient) production yet the FDA has stretched the guidance “because some APIs are sensitizing compounds that may cause anaphylactic shock” and thus it is as important to prevent cross-contamination with APIs as it is with finished products.
Essay on Preventing Crosscontamination in Pharmaceutical Production - Introduction This assignment will be exploring the areas in production how it is regulated and controlled.
It is exploring the rules governing the pharmaceutical production. contamination and cross- contamination in manufacturing facilities. This paper has two objectives: to identify potential contributors of contamination and cross-contamination to discuss concepts on how to minimize and prevent contamination and cross contamination occurring within a manufacturing facility.