The Impact of USP Chapter <800> On Compounding Equipment

2/27/2018
Learn more about USP Chapter <800> and how the OHAUS Explorer can aid with compliance
 
<USP General Chapter <800> focuses on protection of workers by limiting exposure to hazardous drugs.  It sets guidelines for the "receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations". (1)  As any USP guideline with a chapter number less than 1000 is enforceable, compliance with the new guideline may require significant, costly changes to a compounding facility, and the way in which technicians go about their daily business.  While USP themselves do not enforce standards, state level regulations and the FDA will, for most states in the US.Mandatory compliance with the new standards is aways down the road; however, early consideration (if not early adoption) should certainly be given in how best to manage the transition.  While there are various topics addressed to the guideline, one topic that is covered is the handling and maintenance of equipment, such as balances.
 
The use of hazardous drugs in compounding requires a specialized working environment, personal protective equipment, and a strict set of operating guidelines.  One such guideline states that "disposable or clean equipment for compounding (such as mortars and pestles, and spatulas) must be dedicated for use with hazardous drugs".  It is important to note that this requirement is relevant only to utensils or equipment that comes in direct contact with the hazardous substances.  The balance used in the compounding of hazardous drugs (and non-hazardous drugs) typically does not come into direct contact with the compounding components, as containers, weigh boats, etc. are used when dispensing components, and therefore can be used for compounding both hazardous and non-hazardous drugs, provided it is properly decontaminated, cleaned, and disinfected.
 
The process of decontamination will remove hazardous residues from the equipment and can be achieved by wiping the surfaces with alcohol, peroxide, sodium hypochlorite (bleach), or water.  Cleaning is intended to remove organic and inorganic material from the exposed surfaces, and can be achieved by a germicidal detergent (refer to USP Chapter <1072>, which deals with disinfectants and antiseptics).  Disinfection will destroy microorganisms and can be achieved by wiping surfaces with alcohol. 
 
OHAUS balances are easily cleanable and made of chemical resistant materials, such as ABS plastic for the upper housing, cast aluminum for the bases, and 18/10 or 304 stainless steel for weighing chamber or pan surfaces.  ABS plastic has good resistance to sodium hypochlorite (< 20%), excellent resistance to hydrogen peroxide (100%), and good resistance to ethyl and propyl alcohol; however, ABS plastic has very poor resistance to benzyl and methyl alcohol, which should not be used for disinfection as they may damage the housing over time.
 
OHAUS Explorer balances are the number one choice for pharmaceutical compounding applications; their construction and durability are able to endure the necessary cleaning and decontamination processes.  Several models are NTEP and Measurement Canada approved, and are suitable for use in direct sale to the public (or "Legal for Trade") applications.  They are highly accurate, and have features to help with USP minimum weight and GLP/cGMP compliance.  Furthermore, their powerful formulation software ensures that correct component ratios are observed (even in the event of overdosing of an ingredient), and aids in compounding record keeping.
 
Learn more about OHAUS Explorer Analytical Balances
 

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