First, I infer this is a medical device. If it were, say, cleaning production equipment for drugs between batches my questions would not apply.
There are areas in your question that raise questions.
First, what does semi-critical mean and why does it make a difference in cleaning validation?
Because this is a reusable device, I infer the validation is for a cleaning process to include in the IFU. The intent is that the customer performs the cleaning process between re-uses of the device. Your goal is to ensure that it works.
You say, "we have been asked …" Asked by whom?
You are performing process validation for a process in which the customer cannot determine the output. In other words, following 820.75(a), the person performing the cleaning process cannot fully verify it by subsequent inspection and test. The user relies on the instructions in the IFU.
You say, "validation on three devices, three repeat cycles per device, plus a control article". You go on to say, "I know this is common practice". I don't know that it is.
Process validation is an application of design of experiments. You should determine the attributes that influence cleanliness. Then, determine the worst case for each attribute. You want to perform the cleaning validation at the worst-case conditions. Depending on the number of attributes, you are conducting either a full factorial or a fractional factorial experiment.
Typically, you would conduct the validation at the two worst corners of the hyper-cube and the nominal point. This gives you the three devices. Presumably, you are doing three replicates at each worst-case corner and at the nominal point. This gives you information to understand the variability at each point.
In the context, I don't understand the control article. Presumably you clean an uncontaminated device to verify that it is not contaminated. While useful, you need to have ensured that the measurement process for the contamination result produces correct results.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 02-Apr-2020 19:35
From: Anonymous Member
Subject: Cleaning Validation
This message was posted by a user wishing to remain anonymous
Hello RAPS members!
Can anyone point me to the regulation/guidance that requires test articles for cleaning validations to be completed in triplicate, as I have been unable to do so. We have a semi-critical reusable medical device with limited patient contact in a non-sterile anatomical area. We have been asked to complete validation on three devices, three repeat cycles per device, plus a control article. I know this is common practice but wanted to be able to reference a regulation/guidance in our test report. Thanks in advance!