Cleanroom - designed by Tim Sandle People specializing in clean room design for pharmaceutical plants have eagerly explored ..read more

Dr. Tim Sandle discusses some of the common issues encountered in the sterilisation of surgical instruments, using autoclave technologies. He argues that to make a thorough evaluation of sterilisation, reliance cannot be restricted to chemical or biological indicators, and a complete understanding of hazards and physical operating parameters is required. Staff working in decontamination services will ensure that reusable medical devices, such as endoscopes and other surgical instruments and equipment are cleaned, sterilised, and repackaged to high standards.  This article can be read ..read more

 Image created by Tim Sandle Endospores present a concern in controlled environments due to their resistance and indefinite survivability. The production of a spore is part of a sophisticated stress response. Here, the bacterial genome is copied and transferred into the safety of a spore (sporulation). The spore remains dormant until environmental conditions improve. When conditions are favorable, the spore will germinate (generally rapidly) and become a functioning, vegetative cell. This week’s article looks at what endospores are, how they are formed, and their relative resistance a ..read more

  Two hundred years ago, give or take the odd decade, Pseudomonas aeruginosa was an environmental bacterium (1), apparently not one, as far as medical records in the pre-microbiology days can be discerned, associated as a human pathogen (2). Today, P. aeruginosa is associated with a high number of multidrug-resistant infections (3), many of which are nosocomial. Those especially vulnerable to the bacterium are people with underlying lung conditions. It is estimated that P. aeruginosa is responsible for communicable diseases leading to over 500,000 deaths per year around the world, of wh ..read more

The 15-crown-5 crown ether, a cyclic oligomer, and its monomer, ethylene oxide (By Jorge Stolfi CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=92112505) What are oligonucleotides? Oligonucleotides, which cover both deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), are increasingly demonstrating their central value in clinical practice. A notable example is the introduction of customized DNA sequences into immune cells that are genetically engineered to drive these cells to express chimeric antigen receptors (CARs), triggering a new era of cell-based mediated immunotherapy ..read more

  Heat or different biocidal products can be used to reduce microbial contamination in water. This includes strong oxidizing agents like chlorine dioxide and ozone. Historically, the introduction of chlorination to municipal water supplies led to a reduction in cholera and Salmonella (a process regularly in place, for the first time, in England from 1905) (1). Chlorination can be applied to mains water and initial stages of water generation, for pharmaceuticals; however, it is generally not used thereafter with the preferred methods being ozone or heat. Chlorination is an important step ..read more

 Cleanroom calibration (designed by Tim Sandle) Pharmaceutical testing is a critical quality control step that ensures the produced products can withstand specific activities and will perform as patients expect. Friability testing examines tablets’ strength, verifying that they will not break or crumble during transport or handling. Drug assays reveal whether the strength of active ingredients in a tested sample matches its label. Performing these tests and others on the required schedules allows pharmaceutical manufacturers to operate within regulatory requirements.   By Emily New ..read more

IsoBag® (Merck image, with permission)   The revision to EU GMP Annex 1, in August 2022, updated the requirement for Grade A environments used during sterile manufacturing. This was the change in acceptance criteria to ‘no growth’ (from the previous value of 1 CFU). This change not only paves the way for alternative microbiological methods it signalled the shift in regulatory thinking towards the detection of any contamination within the aseptic core being atypical and problematic. One of the dilemmas faced by microbiologists, on the recovery of contamination at Grade A, is whether th ..read more

  Image designed by Tim Sandle A new technique developed at Lawrence Berkeley National Laboratory (Berkeley Lab) will make it much easier for researchers to discover the traits or activities encoded by genes of unknown function in microbes, a key step toward understanding the roles and impact of individual species.   The approach is called barcoded overexpression bacterial shotgun library sequencing, or Boba-seq. This involves taking random fragments of DNA from bacteria of interest and expressing them in host bacterial cells.   The term "barcode" in the name refers to a small ..read more

Wait long enough and it will appear; dust that is, perhaps settling out in a recess in the room you are sitting in. Dust is an amalgam of sloughed-off skin cells, hair, clothing fibers, bacteria, dust mites, bits of dead bugs, soil particles, pollen, and microscopic specks of plastic. In homes and offices, human skin detritus is the largest contributor. In addition, paraffins, nonylphenol ethoxylates, and azo dyes, including 2-bromo-4,6-dinitroaniline, are major chemical components of household dust.   Dust particles are also adept, especially where there is organic matter from human ski ..read more