78 JOURNAL OF COSMETIC SCIENCE
CLEANING AFTER MANUFACTURING: THE fORGOTTON STEP OF SCALE UP
Christopher C. Heisig, Ph.D. and Gurusamy Manivannan, Ph.D.
STERIS Corporation, St. Louis, MO 63166
ABSTRACT
Many cosmetic and personal care companies are expanding their businesses to include the manufacturing of
products with drug claims (e.g., antibacterial soaps, sunscreens). There is growing scrutiny by the FDA on
drug-manufacturers to prove that their cleaning validation programs are compliant (i.e., that they prevent cross-
contamination and inadvertent microbial load in subsequent products). However, even before addressing
cleaning validation, an evaluation of a company's entire cleaning system is needed. This includes evaluating
cleaning equipment capabilities, types of soils, test methods, cleaning chemistry and the impact of cross-
contamination on subsequent products. The selection of proper cleaning agents is vital, since some soils can be
cleaned with water alone or with a commodity cleaner (e.g., NaOH, KOH), while other "difficult-to-clean"
soils warrant additional cleaning mechanisms through the use of materials such as surfactants and chelants.
This presentation will focus on some of the chemistries used for cleaning mixing tanks and vessels and will
provide examples.
INTRODUCTION
In 1993, the FDA issued a guidance document to reinforce cGMP compliance requirements directed towards
cleaning validation. 1 These requirements are aimed primarily at the pharmaceutical industry however, as the
cosmetic and personal care industries continue to expand into new markets, many are becoming manufacturers
of both drug and non-drug products. This ongoing product expansion has required some to review and update
their cleaning strategies and procedures.
The scale-up process, during which the entire manufacturing environment should be taken into account, is a
strategic point where cleaning procedures can be addressed. The cleaning equipment used varies throughout
the industry, including "clean-in-place" systems, agitated immersion, and manual methods. Some companies
have equipment dedicated for the manufacturing of products that are classified as drugs, while others have
equipment that are used for manufacturing both drug and non-drug products. Some employ grouping
strategies, where similar products are made in one manufacturing vessel, and cleaned using one procedure
when possible. When evaluating an entire facility, some even extend the same quality approach to all of their
cleaning procedures, whether a drug product is manufactured in that tank or not. The underlying purpose is to
eliminate residue that can carry over to and contaminate the next (drug) product.
Fundamental to cleaning performance are the actual cleaning chemistries employed. Some companies use
commodity cleaners (e.g., hydroxides, acids, alcohols) to address their needs. Others may need more
''complex" chemistries due to the types of soils they are trying to clean. For example, "formulated cleaning
products" often contain surfactants, chelating agents, dispersants, suspending agents, hydrolyzing agents or
other materials to assist in cleaning the targeted difficult-to-remove soils from product contact surfaces.
The most common materials used in formulated cleaning products are surfactants. These "surface-active"
components provide wetting and assist in solubilizing and/or emulsifying soils. The choice of surfactants used
in a cleaning system is dependent on the intended cleaning use. Such requirements as cleaning time, use-
temperature, concentration, foaming properties and rinsability will help in deciding which surfactant systems
are best for a specific application.
1 FDA. "Guide to Inspection of Cleaning Processes." Division of Field Investigations, Office of Regional
Operations, Office of Regulatory Affairs, July 1993.
CLEANING AFTER MANUFACTURING: THE fORGOTTON STEP OF SCALE UP
Christopher C. Heisig, Ph.D. and Gurusamy Manivannan, Ph.D.
STERIS Corporation, St. Louis, MO 63166
ABSTRACT
Many cosmetic and personal care companies are expanding their businesses to include the manufacturing of
products with drug claims (e.g., antibacterial soaps, sunscreens). There is growing scrutiny by the FDA on
drug-manufacturers to prove that their cleaning validation programs are compliant (i.e., that they prevent cross-
contamination and inadvertent microbial load in subsequent products). However, even before addressing
cleaning validation, an evaluation of a company's entire cleaning system is needed. This includes evaluating
cleaning equipment capabilities, types of soils, test methods, cleaning chemistry and the impact of cross-
contamination on subsequent products. The selection of proper cleaning agents is vital, since some soils can be
cleaned with water alone or with a commodity cleaner (e.g., NaOH, KOH), while other "difficult-to-clean"
soils warrant additional cleaning mechanisms through the use of materials such as surfactants and chelants.
This presentation will focus on some of the chemistries used for cleaning mixing tanks and vessels and will
provide examples.
INTRODUCTION
In 1993, the FDA issued a guidance document to reinforce cGMP compliance requirements directed towards
cleaning validation. 1 These requirements are aimed primarily at the pharmaceutical industry however, as the
cosmetic and personal care industries continue to expand into new markets, many are becoming manufacturers
of both drug and non-drug products. This ongoing product expansion has required some to review and update
their cleaning strategies and procedures.
The scale-up process, during which the entire manufacturing environment should be taken into account, is a
strategic point where cleaning procedures can be addressed. The cleaning equipment used varies throughout
the industry, including "clean-in-place" systems, agitated immersion, and manual methods. Some companies
have equipment dedicated for the manufacturing of products that are classified as drugs, while others have
equipment that are used for manufacturing both drug and non-drug products. Some employ grouping
strategies, where similar products are made in one manufacturing vessel, and cleaned using one procedure
when possible. When evaluating an entire facility, some even extend the same quality approach to all of their
cleaning procedures, whether a drug product is manufactured in that tank or not. The underlying purpose is to
eliminate residue that can carry over to and contaminate the next (drug) product.
Fundamental to cleaning performance are the actual cleaning chemistries employed. Some companies use
commodity cleaners (e.g., hydroxides, acids, alcohols) to address their needs. Others may need more
''complex" chemistries due to the types of soils they are trying to clean. For example, "formulated cleaning
products" often contain surfactants, chelating agents, dispersants, suspending agents, hydrolyzing agents or
other materials to assist in cleaning the targeted difficult-to-remove soils from product contact surfaces.
The most common materials used in formulated cleaning products are surfactants. These "surface-active"
components provide wetting and assist in solubilizing and/or emulsifying soils. The choice of surfactants used
in a cleaning system is dependent on the intended cleaning use. Such requirements as cleaning time, use-
temperature, concentration, foaming properties and rinsability will help in deciding which surfactant systems
are best for a specific application.
1 FDA. "Guide to Inspection of Cleaning Processes." Division of Field Investigations, Office of Regional
Operations, Office of Regulatory Affairs, July 1993.
