4/10/2020 Laboratory Glassware Washer Validation Benefits Go Far beyond Compliance

Article | August 23, 2016

Laboratory Glassware Washer Validation Bene ts Go Far beyond

Compliance
Source: Miele Professional

By Dennis Luisi, Miele Professional Validation Engineer

To appreciate how labwasher cleaning validation can help your organization, it helps to take a
bird’s eye view of its objectives. They are to ensure consistency, quality and compliance with the FDA’s
Current Good Manufacturing Practice (cGMP) regulations — regulations with a laser focus on a
manufacturing process’ ability to create safe and effective products. Again and again.

The validation procedure starts with examining the big picture, the cleaning process, and then investigates the
equipment that plays a pivotal role in executing each task. The purpose of the exercise is to furnish evidence to assure regulators and
customers. This data you gather shows in black and white that your cleaning process will consistently deliver laboratory glassware that
meets required specifications for cleanliness.

Many benefits flow from these objectives. They include:

1. Conformance with Regulatory Requirements

Validating all of the processes involved in bringing a drug to market is not an option. It is an FDA requirement. The most obvious reason
for validation, therefore, is to ensure that your lab glassware cleaning process is in compliance with the FDA’s regulations.

2. Reduced Downtime

Since labwasher validation guarantees residue-free washing results every time, it enables you to avoid downtime due to dirty glassware.

3. Improved Quality

In pharmaceuticals, quality cannot be an afterthought. Because validation focuses the two essential ingredients of pharmaceutical
quality, safety and efficacy, it is a natural step toward a goal of quality improvement. It make sure that medicinal products will
perform according to expectations and the risk of contamination from impurities is brought as close to zero as possible.

4. Reduced Risk of Recalls

Contamination of drugs due to poor cleaning processes can compromise their safety and effectiveness, resulting in health hazards and
even fatalities. Product recalls follow quickly on the heels of tainted drugs, shaving bottom lines, eating up time and sullying
reputations. Clearly, all manufacturers strive to avoid such disasters.

5. Productivity

The validation process makes sure you have a systematic approach that produces good results without fail. In this way, it
improves productivity. Because of the efficiency-boosting power of validation, even labs involved strictly with preliminary research and
discovery that work outside of cGMP environments, are validating their cleaning processes. These labs include, for example:

Non-pharmaceutical labs that create products for clinical testing under cGMP
Contract labs that must use ironclad to avoid cross-contamination between multiple customers’ orders
Quality control labs
Labs involved in preliminary research and discovery

Obviously, there are many benefits to labwasher validation that go beyond compliance with cGMP regulations. These include increasing
quality, productivity, and speed to market as well as reducing downtime and recalls. Given the many advantages of labwasher
validation, you may be ready to get started with the process. How you do so will depend on the precise nature of your operations.
However, there are usually three steps. First, define the cleaning process. Next, describe it in detail, usually including written standard
operating procedures. Finally, qualify the labwasher and validate the cleaning process.

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