Good Manufacturing Practice (GMP) ensures that pharmaceutical products are consistently produced and controlled according to quality standards appropriate for their intended use.1 While permissible microbial levels may be higher in non-sterile manufacturing, GMP principles remain equally critical, as patient safety is still paramount.
The 2022 revision of EU GMP Annex 1 introduced the Contamination Control Strategy (CCS) as a mandatory requirement for sterile manufacturers. CCS involves identifying critical control points and evaluating the effectiveness of cleanroom design, procedural, technical, and organizational controls to manage contamination risks.(2)
These measures should be based on hazard evaluations aligned with ICH Q9 (Quality Risk Management)(4) and continuous improvement initiatives as required by ICH Q10 (Pharmaceutical Quality System)(5) and are equally relevant to non-sterile facilities. The FDA also emphasizes contamination control in non-sterile drug manufacturing, especially for healthcare settings.(9)
It is well established that microorganisms are ubiquitous in the environment, and humans can be a major source of contamination. According to FDA Guidance(9) (10), specifications for Active Pharmaceutical Ingredients should include microbial limits and impurity controls and for non-sterile product types, manufacturers must assess any microorganisms detected in products to evaluate their impact on patient safety, as guided by USP Chapter <1111>.(8)
Implementing a CCS that spans from raw material entry through Controlled Non-Classified (CNC) areas to GMP zones is essential. Effective disinfection throughout this process mitigates contamination risks – from raw material handling to final packaging. This holistic approach reduces bioburden and strengthens proactive contamination control.
Disinfectants play a critical role – not only as a regulatory requirement (per Annex 1, USP, and 21 CFR 211.113)(2), (6), (7) – but also as a practical necessity in maintaining product quality and safety.
The Ecolab Klercide range has long been established as a core disinfectant range for sterile manufacturing facilities. These products are manufactured under GMP conditions (made in cleanrooms for cleanrooms), with demonstrated efficacy against a broad spectrum of microorganisms commonly encountered in a cleanroom environment, considering the unique service materials utilised in manufacturing cleanroom areas. This data (Validex™) is in addition to the registered efficacy data, which gives end users more assurance of how the products will perform in GMP specific environments.
Recognizing the need for consistent, reliable contamination control across all manufacturing areas, Ecolab Life Sciences has a non-sterile Klercide range. This range of products mirror the formulations of their sterile counterparts, and their use can provide additional benefits for both sterile and non-sterile drug product manufacturers in comparison to the use of disinfectant products not intended for use in the Life Sciences industry, such as:
- Manufacturing process: manufactured in a controlled manufacturing environment under a Quality Management System (QMS) that ensures batch to batch consistency, full traceability and quality assurance.
- Product composition: free from perfumes, colorants and unnecessary additives, reducing the risk of extraneous chemical contamination.
- Formulation consistency: consistent formulations across the Klercide range in Sterile, Filtered and non-sterile versions provides recognized, harmonized formulations that can be used across facility zones.
- Product efficacy: the sterile range has registered efficacy claims using appropriate standards for the industry, providing end users with confidence that the disinfectants will deliver the appropriate level of microbial control.
- Residue Management: the non-sterile range is designed with low residue formulations, reducing the need for frequent rinsing and supporting visual cleanliness.
- Single vendor: ability to implement appropriate grades of detergents and disinfectants from a single supplier throughout the facility can simplify supply chain and vendor qualification.
- Streamlined CCS implementation and documentation.
In addition, users of Klercide products benefit from a unified disinfection strategy across Controlled Non-Classified (CNC) and GMP areas, simplifying validation, procurement, and training.
In conclusion, Ecolab Life Science’s expanded Klercide portfolio empowers non-sterile manufacturers to adopt the same high standards of microbial control in areas, such as Cell and Gene Therapy (C>), Oral Solid Dosage (OSD) forms, liquids, powders, Medical Device and tissue culture preparation. This alignment supports GMP compliance and reinforces a facility-wide contamination control strategy.
