The Center for Pharmaceutical Cleaning Innovation (CPCI) puts the situation plainly: in many pharmaceutical facilities, 50 percent or more of manufacturing time is spent on cleaning. For semisolid producers, that figure tends to skew higher. Your products don’t rinse away. They cling, resist and demand extended CIP (Clean-In-Place) cycles.

This isn’t a minor operational inefficiency. It’s a structural constraint on your capacity.

The water, energy, and chemical equation

According to the US EPA’s Lean & Water Toolkit, cleaning process equipment can account for as much as 50-70% of a facility’s total water use in food, beverage, and pharmaceutical manufacturing.

IMA Group’s research confirms similar figures: more than two-thirds of water consumption in manufacturing facilities is directly related to cleaning.

Detergents and chemical use

For semisolid formulations, where oil phases, waxes, and petrolatum resist standard detergent concentrations, the numbers compound.

Alconox technical documentation recommends detergent concentrations of 1-3% for ointments and lotions, compared to the 1% typically used for routine aqueous cleaning. More stubborn residues may require concentrations up to 3-5%.

Inefficient work

IMA Group illustrates the scale: in some pharmaceutical facilities, CIP can consume approximately five hours per production day.

That’s five hours of equipment sitting idle. Five hours of labor allocated to cleaning rather than production. Five hours of water, energy, and chemicals flowing through pipes instead of product.

Why semisolids are different

The FDA’s Topical Drug Products Inspection Guide explicitly acknowledges the challenge. The guide identifies ”dead spots” in mixing vessels, areas where quantities of the formula remain stationary and are not subject to adequate mixing or removal.

Unlike liquid pharmaceuticals that flow and rinse, viscous products grip surfaces. Standard spray patterns fail and mechanical intervention becomes necessary.

This creates a cascade of complications:

• Extended cycle times.

According to GXPCellators, standardized automated CIP cycles run 20-45 minutes, while manual cleaning extends to 45-90 minutes. Laminar’s CIP research documents seven-step CIP processes in dairy and pharmaceutical facilities typically running 60-90 minutes, with extended cleaning for potent or difficult residues reaching 5-7 hours.

• Validation complexity.

The EMA’s guideline on health-based exposure limits (HBEL) requires toxicology-based carryover limits for shared facilities. For multi-product operations producing different semisolid formulations, each product changeover demands documented cleaning validation. The ISPE Cleaning Validation Lifecycle Guide addresses this comprehensively, and Pharmaceutical Engineering published a dedicated article on the ”Life-Cycle Approach to Cleaning Topical Drug Products” in January 2023.

• The swab-and-test burden.

Cleaning validation for semisolid equipment typically requires 100-300 swab samples per validation cycle, with minimum three consecutive successful cycles. Each sample requires analytical testing. The documentation load alone represents significant QA resources.

What this costs you

The calculation is straightforward. If your facility operates on 50% cleaning time, you’re effectively paying for twice the capacity you’re using.

Every additional CIP hour represents:

• Direct labor cost for operators monitoring and documenting the process
• Water consumption at industrial rates (typically €2-5 per cubic meter in Western Europe; $8-15 per 1,000 gallons / 3,785 liters at most US urban facilities when including wastewater charges)
• Energy for heating CIP solutions to effective temperatures (typically 60-80°C / 140-175°F)
• Chemical costs for detergents, sanitizers, and rinse agents
• Wastewater treatment or disposal fees
• Opportunity cost: production you’re not running

For operations running multiple SKUs with frequent changeovers – common in contract manufacturing where product lifecycles have compressed from years to months – the cleaning burden multiplies with every batch change.

Understanding the regulatory baseline for ”empty”

Here’s a number worth knowing: under US EPA regulation 40 CFR 261.7, a container of 119 gallons (450 liters) or less is considered ”empty” when no more than 3% by weight of the total capacity remains as residue. For larger containers, the threshold drops to 0.3%.

This regulation applies to hazardous waste containers generally; it makes no distinction for viscosity. But it establishes a regulatory baseline: up to 3% product loss is the accepted standard for what ”empty” means.

For high-value semisolid products, that residue represents significant cost walking out the door with every container.

A different approach: eliminating the container cleaning step

The traditional assumption is that cleaning is unavoidable. Bulk and semi-bulk containers must be cleaned between batches. That’s the cost of doing business.

But what if the container itself never needed cleaning?

This is the principle behind single-use flexible IBCs for semisolid handling.

How to stop product loss during CIP changeover

Instead of filling rigid steel containers that require intensive CIP between uses, product is discharged into 1000-liter Fluid-Bags (264 US gal) that are used once, eliminating the cleaning cycle entirely for that stage of the process.

Evidence from production floors

Bayer Supply Center Grenzach, the center of excellence for semi-solid pharmaceuticals, made this transition for their ointment operations. Steel containers had left excessive residue from high-value products and required intensive cleaning between batches.

Dr. Oliver Maunier, Department Head of Bulk Production, describes the shift:

”In earlier days we needed to use steel containers, which had to be cleaned and everything. Nowadays, we save a lot of time. We are able to store the bulk material in the bags, and we deliver them directly to the packaging department, where they can be filled into tubes.”

The result: Bayer achieves nearly complete product extraction while eliminating container cleaning entirely. The closed system maintains pharmaceutical standards from production through final tube filling.

Weleda’s Arlesheim facility faced a different challenge; handling new high-viscosity cosmetic products with no suitable technology on-site. Metal container systems required cleaning between batches and left residue that represented lost product.

The outcome with Fluid-Bags: residue levels dropped to less than 1%, recovering product that previously went to waste. The closed system eliminated container cleaning entirely while maintaining cosmetic hygiene standards throughout production.

Didier Chiquet from Weleda’s Filling/Packaging Production:

”We use the Fluid-Bags to move the products, from the production area into the filling and packaging area. Squeeze Solution is a very user-friendly system and it’s helped us to reduce waste.”

Explore the Weleda case study.

Toyota Manufacturing UK provides data from outside pharma and cosmetics; their Burnaston plant handles sound dampening materials with similar viscous properties.

The former system: steel totes with double ram presses that left approximately 95 kg (209 lbs) of residual material per container and required 56 minutes for each changeover. The tote and ram press system also required a cleaning process that produced problematic wastewater requiring proper disposal.

After switching to 1,000-liter (264 US gallon) Fluid-Bags with automatic Discharge Rollers:

• Changeover time: From 56 minutes to 10 minutes (82% reduction)
• Residual waste per container: From 95 kg to approximately 30 kg (209 lbs to 66 lbs, a 68% reduction)
• Wastewater from cleaning: eliminated entirely

The single-use system removed the cleaning step from the process entirely.

The economic comparison

The objection is predictable: single-use containers have a per-unit cost. Rigid containers are reusable.

But reusable containers aren’t free. They carry costs that rarely appear on purchase orders:

• CIP cycle time (labor, utilities, chemicals)
• Cleaning validation (QA resources, laboratory analysis)
• Wastewater treatment or disposal
• Container reconditioning and inspection
• Storage space for cleaned containers awaiting use
• Product residue left in containers (at the EPA’s 3% threshold, that’s the regulatory baseline for acceptable loss)

When Bayer, Weleda, and Toyota made the transition, they weren’t choosing higher costs. They were eliminating costs that had been invisible in their existing operations.

The question to ask

If your facility spends half its time on cleaning, what would it mean to recover even a portion of that capacity?

Not through faster cleaning. Not through more efficient CIP cycles. But by removing the cleaning requirement entirely for your rigid bulky containers.

The products still need to meet specifications. The equipment still needs validation. The process still needs documentation. But the container, the vessel that holds your product between production and filling, doesn’t have to be a cleaning burden.

It can be a pre-sanitized, single-use solution that’s ready when you need it and gone when you’re done.

Squeeze more capacity. Waste less time on cleaning.

Find out more by exploring the Squeeze solution.