ASEPTIC MANUFACTURING & DECONTAMINATION VALIDATION
The sterile cleanroom is used by a wide variety of industries, including pharmaceuticals, as it provides a self-contained environment that is completely clean of chemical vapours, microorganisms, aerosol particles, and other pollutants and pathogens. Pharmaceutical cleanrooms function by controlling the amount of particulate contamination, which is represented in industry used performance grades called ISO. The level of atmospheric contaminant is measured in parts per cubic meter (PPC), so as example an ISO 9 cleanroom, the lowest grade of cleanroom, maintains a PPC of 35,000,000 (particles greater than 0.5mm in diameter) and this is comparable to your average urban environment.
Industries like pharmaceuticals rely on cleanrooms to produce and maintain a stable, pollutant free environment, as even the smallest amount of contaminants or microorganisms can have disastrous effects on the development of test results or key medicines.
Pharmaceutical personnel who will be working within the cleanroom environment must study courses in contamination control theory, as maintaining the contaminant free space is crucial to the role. Clothing, gowning and de-gowning procedures, and showering are all steps taken to ensure pollutants are minimal.
Pharmaceutical personnel may be required to wear anything from a fully enclosed suit with self-contained breathing apparatus to just the standard lab coat, depending on the pharmaceutical manufacturing process being performed in the cleanroom.
All cleanroom attire is fairly standard however, and can include shoes, face masks, boots, aprons, gloves, frocks, bouffant caps, beard covers, gowns, and shoe covers. Pharmaceutical manufacturing personnel will be required to wear clothing in line with the ISO grade requirements of the cleanroom.
The clean environment produced by the cleanroom is crucial to the aseptic manufacturing procedures of the pharmaceutical industry. Due to the nature of pharmaceuticals, the sterility produced via aseptic manufacturing is of the upmost importance as any bio-contamination can have serious implications on the end user.
Aseptic manufacturing and filling are processes used when terminal sterilisation practices (steam autoclaves, Ethylene Oxide, dry heat ovens, or irradiation) would affect the final drug or product. Hydrogen peroxide vapour is a powerful and effective steriliser of spore-forming bacteria and is commonly used in pharmaceutical aseptic manufacturing and filling practices where irradiation could cause the denaturing of medicines, samples, etc.
Hydrogen peroxide vapour quickly breaks down into water and oxygen, making it environmentally safe as well as safe for use in pharmaceutical aseptic manufacturing. Hydrogen peroxide vapour is also capable of inactivating a wide variety of bacteria, viruses, and spores and fungi, making it a capable decontaminant.
Sterility is vitally important to pharmaceutical manufacturing and always tested using biological indicators. Biological indicators are the gold standard in testing the sterility of a cleanroom or environment, yet are traditionally slow to culture and therefore gain insight into the success or failure of a sterilisation procedure. Now the pharmaceutical manufacturing industry is looking to enzyme indicators as a faster, cheaper, and more reliable alternative.
Unlike the highly resistant spores used by biological indicators, enzyme indicators are developed from the thermostable enzyme Adenylate Kinase, found in the thermophilic bacteria Supholobus acidocaldarius. The Adenylate kinase undergoes a luciferin reaction which emits light relative to microorganism deactivation, giving instant, measurable results of the efficacy of sterility protocol. With instant results, pharmaceutical manufacturing plants will no longer have to stop operations while waiting on the biological indicator test results to come back.
At the helm of enzyme indicator development is Protak Scientific. Protak Scientific is looking forward to bringing this faster and more reliable technology to the scientific community, and is currently commercially testing enzyme indicator technology.