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Water droplet acceptance criteria – the BioPhorum guide

3 July 2023
Advanced Therapy Medicinal Products
Drug Substance
Donna Hamilton
Global Change Facilitator

The pharmaceutical and biotech industries are being asked to deliver medicines faster and cheaper, while continuing to improve compliance to ensure the safety and efficacy of drugs.

A big risk for multi-product facilities is cross-contamination because they use different products within their bioreactors. Yet the pressure to quickly move from one product to another means there is little turnaround time between products being manufactured.

One aspect of this environment is that health agencies require cleaned equipment to be drained/dried following cleaning and before use or storage. However, the amount of residual water is a common question from auditors and regulators, but having a completely dry vessel is neither practical nor necessary.

Unfortunately, there is currently no industry standard or guidance for water droplet acceptance criteria, meaning each company must develop its own solution.

To bring clarity and consistency to this area, we have published Droplets vs dryness and the requirement for equipment post-cleaning, which not only states that water droplets are acceptable – but explains why.

What kind of water is it?
Companies spend a lot of time revalidating and cleaning their columns, but there will always be water left once this is done. But what kind of water is it? Is it sterile? Is it clean? Does it contain product left from the process that has just been completed?

Our paper gives a justification and rationale for how much residual moisture is acceptable after cleaning for the routine reuse of equipment. We also give an overview of the requirements for equipment dryness in routine use or long-term storage and provide a risk-based justification for these storage conditions. In addition, it considers the practical considerations and strategies for protecting cleaned equipment.

Using this paper will give confidence that after you have done your validation and cleaning, you can be certain of the results, so you will not have to collect samples and retest them after every clean. If you have followed these procedures correctly, the remaining condensate will be sterilized – this will let you reduce the extra quality steps needed for routine cleaning, saving you time and money.

Our paper is aimed at those involved or leading cleaning validation programs. However, it will also benefit those who provide oversite to those programs as it provides the rationale for varying degrees of dryness based upon the equipment’s immediate intended use (production or storage).

Do you need a unified approach to justify your equipment’s dryness level? And a basic framework for evaluating the risks around water droplets in your systems after cleaning? Then download this paper now.

For more information, download the paper here and contact Donna Hamilton, Global Change Facilitator, at donna.hamilton@biophorum.com

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NEWS
Now you can have a simple, compliant, and valuable equipment revalidation strategy

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

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Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

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Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

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Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

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BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

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