DECONTAMINATION Jonathan Newell reviews Cherwell
Laboratories’ pharmaceutical cleanroom decontamination guide.
s manufacturing cleanrooms face increasingly stringent contamination control requirements, different types of contaminants are coming into play. Healthcare and pharmaceutical labs have always had to face the issue of maintaining sterile environments
as well as keeping particle counts down although this may be a new arena for cleanroom specialists involved in other industries. To help engineers and scientists find out more about keeping cleanrooms sterile, Cherwell Laboratories has published its “The pharmaceutical lab’s pocket guide to cleanroom decontamination”.
MORE THAN JUST PARTICLES Originally, manufacturing cleanrooms were developed to specifications to reduce the size and quantity of airborne particles. Once clean airflow has been established and maintained, surface contamination can also be maintained at acceptable levels. To determine the level of contamination and provide specifications for contamination free thresholds, ISO 14644- 1 makes provisions for 9 classes of cleanroom with ISO 9 being the “dirtiest” and ISO 1 being the level with the smallest particle size and the least number of them in a given volume of air.
All of this will be old hat to experienced cleanroom operators and engineers but there’s more to contamination than particles. Chemical contaminants can corrode or degrade components, magnetic contamination can destroy computer disk drives at the manufacturing stage and even vibration can be considered a contaminant in nano-manufacturing environments. However, the big threat in the pharmaceutical and healthcare industries is biological contamination. Cleanrooms in these industries need to meet stringent particulate
The germ burden in pharma
❱ ❱ Disinfectant needs to be supplied sterile and wrapped in a suitable container for use in aseptic areas
contamination control standards as well as being sterile to prevent biological contamination. Bicester based Cherwell Laboratories is a specialist in
environmental monitoring, cleanroom bio-decontamination and process validation for healthcare, pharmaceutical and industrial cleanroom operators. The company recently released its guide to cleanroom decontamination for personnel in these industries.
MEETING THE STANDARDS Cleanroom validation for Pharmaceutical industry manufacturers involves two stages of meeting the required standards initially and then maintaining them throughout the operation of the cleanroom. Two standards are applicable in the Pharma industry. ISO
14644-1 covers particulates with ISO 14644-2 covering the schedule for monitoring for continued compliance. ISO 14698 (parts 1 and 2) covers biocontamination control. There are other regulations which cover the materials and equipment used for decontamination work. For maintaining bio-cleanliness, Cherwell Laboratories recommends following the EU European Medicines Agency – Good Manufacturing Practice (GMP) in conjunction with the ISO standard.
DECONTAMINATION Cherwell details two levels of cleaning up biological contamination including routing maintenance operations and remedial decontamination after a filter failure, a shut down or what it terms a “bioburden outbreak”. This term refers to the condition of having biological contamination that exceeds the microbial limit as defined in the standard and is normally discovered during routine maintenance testing to assure continued conformance to the standards.
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