I am working in a CRO- bioanalytical department.
I want detail procedure about, how to perform glassware cleaning validation, what are the acceptance criteria and what other steps i should follow to perform glassware cleaning validation
Thank you in advance,
Devangi Soni
Do not expect lab glassware to be included in the processing equipment cleaning validation program. Glassware must, of course, be clean and the CGMPs consider lab equipment to be included in the scope of 211.67. The assurance of cleanliness is best assessed by inspecting laboratory procedures for the use of non-dedicated glassware and other equipment, method validation (ruggedness, e.g.), and the absence of extraneous or interfering data in the results of sample analyses. Lab cleaning procedures may include repetitive rinses with the solvent used to prepare the analyte and oven drying. The equipment need not be swabbed or otherwise tested to ensure removal of potentially contaminating residues. A firm may elect to sample its glassware for residual contamination to exclude or explore the possibility of interference in the case of particularly sensitive analyses or highly difficult to clean compounds. The possibility of carryover contamination affecting a method’s performance or integrity of the results is generally considered to have a low risk to product or consumers. Contaminated lab equipment, however, should not be a frequent excuse for rejecting or discarding aberrant results. We expect that firms maintain lab equipment in a clean and sanitary manner so as to provide confidence in the results of analysis.
References:
Preamble to the Good Manufacturing Practices for Human and Veterinary Drugs, Federal Register, September 29, 1978, pages 45040-1, paragraphs 167-175
http://www.fda.gov/cder/dmpq
21 CFR 211.67
Guide to Inspections of Cleaning Validation, 1993
Human Drug CGMP Notes editions Dec. 1998, Sep. 1998, Sep. 1997, Jun. 1995
We have often found that poor glassware cleaning practices have had the potential to negatively affect the integrity of results generated in our labs due to the presence of “ghost” responses and even interference with principal peaks (resulting in some lost time and very angry Production Managers) which cannot be adequately explained (Of course, you cannot tell an auditor that the glassware was probably dirty, you’d have your butt handed to you…and not very nicely!!!)
Anyway, while the contamination from glassware does not necessarily affect the method’s performance from a purely analytical perspective, it can make life uncomfortable for you. WE have decided to validate our glassware washer, focussing the OQ/PQ on a Cleaning Validation-type exercise and glassware calibration verification.
I am having an audit today with a potential customer and she asked to see a cleaning validation for our glassware and pipette washer. She is asking about rinse water testing results on this validation. Obviously we do not have a validation for this, but I will have to come up with something. I know it would be vary based on the use of the glassware: general erlenmeyers used for titrations being the lowest risk and volumetric flasks for GC work. We currently wash GC glassware with Sparkleen, rinse with tap, rinse with DI, and dry in the oven until dry. I need to know what I need to test for: soap residue and/or one of the approx. 60 chemicals that could be present in trace amounts. Please help. Thanks!
Normally the gallsware validation remains same as the process equipment the trace detection is the method of rinse water analyses & one should go with that in my opinion. Obviosly what should be checked is based on the matrixing & scientific justification over the same.
I normally follow the approach during audits i.e. Don’t prepare the doc just to satisfy the man in hurry, must be robust for future…give response shall be performed (Depends on business risk & end decision of user).
Happy Reading !
Thanks Indore.