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Improving production uptime by reducing cleaning times
For maximum business benefit, it could be argued
cleaning validation
studies should concentrate on production requirements as much as
cleaning requirements. Increased cost savings could be attained, for
example, by reducing a 12 hour cleaning turnaround time to 6 hours,
equalling savings every day on all batches. Our multi-disciplinary
approach, combining engineers, chemists and microbiologists enables
compliance issues to be met, but also the most efficient production
solution.
Demystifying cleaning validation
The regulatory authorities expect a technically sound rationale for the
approach taken to remove residues from product contact surfaces. The key
requirement being that cleaning needs to be repeatable, demonstrable,
justifiable and measurable. This is achieved by setting priorities that
are based on a risk assessment of the entire manufacturing process.
Knowledge of the product, cleaning agents and the methods to remove
residues, enables a robust rationale to be developed, justifying
acceptance criteria and the type of
analytical testing that should be
conducted, whether for chemical or microbiological contaminants.
Sampling and testing requirements for cleaning validation
With product formulation and cleaning process knowledge, methods for
recovering residues from 'worst case' surfaces can be developed. Samples
can be tested using scientifically justifiable and validated analytical
methods, whether these are pH or conductivity, total organic carbon, HPLC or related to the removal of objectionable
microbiological
organisms.
Acceptance criteria for cleaning validation
On so many occasions 10ppm is presented as the limit for
TOC in rinse
waters, with no scientific justification for this limit. Acceptance
criteria are defendable, when they have been calculated based on a
fundamentally sound and scientific basis. This means developing a
detailed rationale for the entire approach showing the understanding and
control that regulatory authorities expect.
What next?
Honeyman Group Ltd has the expertise to 'de-mystify' the black art of
cleaning validation, to help clients develop an approach that is
scientifically robust and defendable to regulatory inspectors. Our
experts can perform a 'gap analysis' of clients' current approach vs
regulatory expectations or coach clients through each step. Honeyman can
conduct a 'risk assessment' with support in the development of a
rationale, writing a validation master plan based on substance and with
development of protocols and support in their execution. Honeyman has
the expertise to develop and validate analytical methodology and the
resources to test swabs or rinse samples, whether that is for
disinfectant efficacy or quantification of residues, with the expertise
to interpret results and write professional, defendable reports.
Our multi-disciplinary approach can address
chemistry, microbiology,
engineering, production and regulatory concerns and opportunities.
typically this includes:
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Facility cleaning
regimes
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Disinfectant efficacy
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Manual equipment
cleaning
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Automated cleaning
processes
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Analytical methodology
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Cleaning/turnaround
procedures
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