We develop customized maintenance programs tailored to your specific needs, ensuring consistent cleanliness and compliance throughout your facility.

Cleanrooms are traditionally designed to minimize microbial contamination. However, recent studies have revealed a diverse range of microbes in cleanrooms, challenging the assumption of a completely sterile environment.

While cleaning efforts reduce the abundance of microbes, they do not significantly impact the diversity. Archaea, including survival specialists like bacterial spore formers and halophiles, have been found alive in cleanrooms.

Cleanrooms must meticulously control temperature, humidity, and atmospheric pressure levels. These factors are critical for maintaining consistency, reliability in test results, and minimize particulate contamination.

Stringent cleaning practices correlate with the emergence of antibiotic-resistant microbes. This poses challenges for containment and potential economic losses.

All cleaning procedures should be validated (shown to be effective) under specific conditions of use. These conditions of use are specified in the SOP.

Employees cannot deviate from the SOP or alter the conditions of use without risking invalidating the cleaning methods. For example, it would seem logical that adding using a stronger sanitizer than the procedure requires would make cleaning faster or better. This is not always the case as you may alter the properties of the solution (e.g. lowering the pH) thus rendering it less effective.

The relevant GMP rules are to only clean under validated conditions and strictly follow procedures. 

The written procedures describe the required conditions under which cleaning is optimal.

These conditions must be followed precisely or you risk unacceptable results. For example, too strong of a solution used in sanitizing could damage the surfaces of counters, tabletops, equipment and accessories. The pH balance has to be accurate or you could end encouraging bacteria growth instead of eliminating it.  Also, the type and quality of the water used can impact results. 

Your SourceOne team understands all of the variables and dials it all in for best results:

Title: Key Components for Optimal Cleaning Conditions

• Strength of the cleaning or sanitizing agent (e.g., 2.0% v/v)
• The type of water or solvent to be used
• The pH of the cleaning agent
• The temperature of the water to be used
• How much to dismantle equipment before cleaning commences
• The contact or residence time for the sanitizing agent on the surface
• What agents to use to clean off the sanitizing agent
• What standard of water to use in the final rinse (GMP, for example, requires purified water for injection as the final rinse)

One essential GMP rule is the keeping of detailed cleaning records. Cleaning records prove that cleaning took place and evidence of the cleaning outcomes.

For example, the surfaces are visually clean or the results of rinse water tests.

The records must also identify who did the cleaning and when and must be signed.

For automatic cleaning procedures such as clean in place (CIP), the cycle conditions are usually automatically monitored and the conditions recorded.

Cycle conditions may include the temperature, flow rate, time, concentration of solvent, and solvent agitation time. Often, CIP systems have alarms when something goes wrong.

The completed and signed records should be attached to the records since they provide the only objective evidence that cleaning has occurred.

• The facility must be regularly cleaned. Particular emphasis is placed on areas or rooms where product is processed.
• Particular emphasis is placed on effectively cleaning all equipment in contact with the product, and it must be cleaned according to validated and detailed procedures.
• All equipment in processing areas not in contact with the product needs regular cleaning to prevent dust and dirt buildup.
• The inside of the factory should be regularly cleaned, but particular attention should be paid to the processing and storage rooms. The floors, surfaces, benches, walls, and ceilings should undergo cleaning at defined intervals.
• Cleaning and sanitation also apply to any equipment in contact with the product during manufacture, such as production and packaging equipment, transfer lines and tanks, and storage containers and drums.

The nature of Life Sciences work creates serious challenges for facility managers due to the need for high standards of cleaning required to combat contamination from bacteria, mold and virus. 

We begin with an assessment to determine the standards and protocols required to achieve the appropriate level of cleanliness for your specific facility. This includes ISO cleanroom standards and BSL (Biological Safety Levels).

GMP stands for Good Manufacturing Practices which is a system that consists of processes, procedures and documentation that ensures products are consistently produced and controlled according to set quality standards. Implementing GMP cleaning protocols can help cut down on losses and waste. Overall, it protects both company and consumer from negative safety events.

Your SourceOne team undergoes comprehensive training and thorough classroom and hands-on instruction in cleanroom and controlled environment practices, tailored to the unique needs of life science facilities including biotechnology, pharmaceuticals, and medical devices.

Biopharma products demand a strict stand against contaminants of all types. Additionally, in the ever-evolving realm of biopharma, where new innovations emerge frequently, GMP cleaning remains the consistent foundation ensuring product and worker safety and efficacy.

If you are launching a new Life Sciences venture and need to develop a cleaning and sanitation SOP, we can provide consulting services that include an audit of your facility and operations. Together we will build a detailed cleaning plan that conforms with all necessary ISO/GMP procedures and protocols, along with Good Documentation Practice log books.