GMP Washing in Biopharma: From Clean Enough to Verifiably Clean

Washing

Cleaning Out Of Place (COP)

Suncombe specialise in the design and manufacture of high-performance automated COP Washers to wash contaminated IBCs (intermediate bulk containers), mobile vessels, tanks, parts, components or other items which may be moved in and out of the washing chamber.

When correctly applied automated washing provide several benefits to the user including validated repeatable, cleaning performance, improved health and safety, reduced costs for labour and utility consumption.

Washers may be designed as “total loss” systems, where the washing media is used once only before passing to drain or “recovery” systems, which recycle some of the washing media for part of the cleaning cycle.

If necessary washing cycles can conclude with the application of sanitiser.

Where contamination is not soluble in water, our systems may utilise solvents as the washing media, which requires a range of additional safety measures.

The key to successful washing is the design of automated systems which are effective at cleaning and repeatable in all possible circumstances. As automated washing reliability has improved so has its application in increasingly demanding and highly regulated industries where hygiene and avoidance of contamination is paramount, including pharmaceuticals and bio-waste.

The science of washing is based on applying the required amount of energy to the equipment to ensure that it is cleaned. The energy is primarily provided by the solution temperature (thermal energy), the use of detergent or solvent (chemical energy) and the application of kinetic energy for a defined time period. We use the ASME BPE Design Standards for GMP Washers, to ensure a repeatable, validatable wash for all of your components.

All washers are made to Suncombe’s exacting sanitary manufacturing standards.

Good Manufacturing Practice

Good Manufacturing Practice (GMP) washing has become a critical control point in modern biopharmaceutical facilities, particularly as sites move to multiproduct manufacturing and handle increasingly potent, sensitive, or high-value therapies. Automated GMP washers provide validated, repeatable cleaning and drying of parts and components that come into contact with product streams, utilities, or cleanroom air, supporting both product quality and inspection readiness. In this context, washing can no longer be treated as a background utility; it is a documented, auditable process that directly supports the site’s contamination control strategy and cleaning validation lifecycle.

Why GMP Washing Matters in Biopharma

The primary purpose of GMP-compliant cleaning is to prevent cross-contamination between different products, batches, and processes, thereby protecting patient safety and batch integrity. Even trace residues of active pharmaceutical ingredients, excipients, cleaning agents, or microbial contaminants left on equipment surfaces can become unwanted impurities in subsequent batches, especially in multiproduct facilities. Regulators explicitly expect manufacturers to validate cleaning procedures for product-contact equipment and to demonstrate, with data, that residues are reduced to acceptable levels rather than simply relying on visual cleanliness.

In biopharmaceutical production, many critical surfaces are still cleaned manually, which can introduce variability, increase operator exposure, and make cleaning validation harder to defend. Automated parts washers address these weaknesses by controlling key process parameters such as time, temperature, spray coverage, and detergent concentration, thereby standardising the cleaning step and making it easier to document, qualify, and monitor. As a result, GMP washing is increasingly seen as a core contributor to contamination control, not just a housekeeping activity.

Regulatory Drivers and Cleaning Validation

Guidance from agencies such as the FDA and EMA places clear responsibility on manufacturers to ensure that equipment is cleaned so that residues do not compromise the safety, identity, strength, quality, or purity of medicines. While regulations may not prescribe specific technologies, they require firms to develop written, validated cleaning procedures, supported by risk-based cleaning validation protocols and appropriate analytical methods. Modern interpretations also embed cleaning into the site-level contamination control strategy, treating parts washers as critical systems whose recipes, alarms, and logs must withstand inspection scrutiny.

Cleaning validation is now understood as a lifecycle rather than a one-off exercise, typically following three phases: process design, process qualification, and continued process verification. During process design, manufacturers define critical quality attributes (such as acceptable residual levels), identify critical process parameters (e.g., time, temperature, detergent dose, spray pattern), and select worst-case soils and load configurations. Process qualification then demonstrates that the chosen washer cycles consistently meet acceptance criteria under routine and worst-case conditions, after which continued verification relies on monitoring, periodic review, and change control to maintain the validated state over the equipment lifecycle.

From Manual Cleaning to Automated GMP Washers

Traditional manual cleaning places heavy reliance on operator technique, access to complex geometries, and consistent application of detergents and rinsing, which can be difficult to standardise and verify. Manual approaches may remain suitable for some low-risk tasks, but they become increasingly fragile in high-throughput or multiproduct environments, especially where potent compounds or biological materials are involved. Automated GMP washers, by contrast, encapsulate the cleaning process in defined cycles with controlled parameters, allowing sites to reduce variability and operator dependency.

Automated parts washers in the pharmaceutical sector are designed to achieve reproducible cleaning of components such as change parts, IBCs, mixing tools, trays, filter housings, and other product-contact items. These systems typically provide programmable cycles that combine pre-rinse, detergent wash, post-rinse, and drying, with all parameters monitored and documented to support validation and audit trails. High-grade stainless steel construction, sanitary design, and compatibility with multiple regulatory frameworks (EU GMP, FDA, and others) make them suitable for the demanding conditions of biopharmaceutical manufacturing.

GMP Washing Inside the Contamination Control Strategy

Recent regulatory updates emphasise that cleaning must be integrated into the site’s overall contamination control strategy, establishing the “initial state of cleanliness” for components entering aseptic or high-grade environments. This perspective recognises that ineffective cleaning can undermine even robust disinfection or biodecontamination regimes, since chemical or microbial residues shielded by residues may not be removed by later steps alone. Consequently, the performance and documentation of GMP washers are increasingly scrutinised during inspections, alongside sterilisation and environmental monitoring systems.

Within this framework, automated GMP washers contribute to wider risk-reduction goals by enabling consistent cleaning outcomes, minimising cross-contamination risk between batches, and reducing operator exposure to potent residues. They also help standardise cleaning approaches across sites or lines by embedding agreed recipes and acceptance criteria in equipment control systems, which supports harmonisation and knowledge management in global organisations. This alignment with contamination control strategies underpins inspection readiness and helps demonstrate that cleaning risks are being actively managed rather than assumed away.

Key Design and Performance Considerations

Effective GMP washing depends on a combination of mechanical action, appropriate chemistry, and well-controlled time and temperature, all of which must be defined and justified during process design. Washers should deliver uniform spray coverage, including to hard-to-reach internal surfaces, while avoiding dead zones where soils could persist. Detergent selection must balance cleaning power, material compatibility, and ease of rinsing, with acceptance criteria and analytical methods defined for residuals.

From a compliance and validation standpoint, automated washers should provide accurate and traceable recording of cycle parameters, alarms, load configurations, and recipe versions. Data integrity features such as secure audit trails, controlled user access, and electronic batch records support both routine review and regulatory inspection. The ability to map and qualify different load patterns, including worst-case configurations, is also important to demonstrate that cleaning performance remains robust as operations scale or diversify.

Benefits of GMP Washing for Biopharma Operations

For biopharmaceutical manufacturers, investing in robust GMP washing capability delivers several operational and strategic benefits beyond basic compliance. Automated parts washers reduce cleaning time and manual handling, increasing overall equipment effectiveness and supporting higher production throughput. They also minimise the risk of batch rejection due to cleaning-related deviations, which can have significant cost and supply implications for high-value or time-critical products.

In addition, replacing manual processes with validated automated washing reduces operator exposure to potent compounds, cleaning agents, and hot surfaces, contributing to occupational safety objectives. Standardised, recipe-driven cleaning makes it easier to introduce new products or scale existing processes, as cleaning strategies can be extended or adapted in a controlled way as part of the validation lifecycle. Overall, well-specified GMP washers help organisations demonstrate that they treat cleaning as a critical, data-driven process aligned with patient safety and regulatory expectations.

WASHING

WASHING

Testimonials

Washing FAQs

Cleaning out of place or COP refers to the process where moveable or portable equipment, such as IBCs, mobile vessels, parts or components, is removed from the process, placed into a dedicated washing chamber or station, and cleaned using automated or semi-automated methods.
The science of cleaning out of place washing is based on combining three forms of energy: thermal (heated fluids), chemical (detergents or solvents), and kinetic (spray impact, agitation), applied for a defined time period.
Our cleaning out of place washers are used in wash stations for intermediate bulk containers (IBCs), mobile vessels, tanks, parts, trays, and equipment in industries such as pharmaceuticals, biotech, food & beverage, dairy, personal care, and critical manufacturing.
IBCs, totes, cube tanks, bulk boxes, trays, pallets, parts like valves or fittings, pump housings, hose assemblies, and components can be transported into the washer.
First, start by defining your cleaning targets (what items, contamination, throughput). Use Suncombe’s Washer Selection Guide to determine size, flow rate, spray coverage, heating/cooling, and automation level. We ensure the system is designed for validation, meets your industry standard, and has the correct documentation. nation, particularly research laboratories, biocontainment/bioproduction facilities, pharmaceutical manufacturing, and hazardous waste treatment plants.