High-Risk, High-Care & Ambient High-Care Segregation Procedure

Keep pathogen control steps visible within the controlled site map

The site map maintained under the Layout, Product Flow & Segregation Procedure is the controlled site layout record used for production zoning. The High-Risk, High-Care & Ambient High-Care Segregation Procedure requires Technical / Quality Management to identify the pathogen control step or steps applicable to the manufacturing process and Site Management to ensure their locations are included on the current map. General site-map maintenance and wider movement and process-flow controls remain within the Layout, Product Flow & Segregation Procedure.

Define segregation and movement controls for high-risk areas

Where high-risk areas form part of the site, they must be physically segregated from other areas. Technical / Quality Management defines the segregation controls, while Operations Management maintains the defined product, material, personnel and waste routes and other controls established for routine production.

The control definition considers product flow; materials and packaging; equipment; personnel movement; chemicals; waste; air flow and air quality; and utilities, including drains. Structural, equipment, personnel-entry, waste, utility and other specialist requirements remain governed by the related procedures, keeping the High-Risk, High-Care & Ambient High-Care Segregation Procedure focused on how those factors are addressed within high-risk segregation.

Protect high-risk segregation at transfer points

Transfer points and entry practices are treated as specific elements of high-risk control. Technical / Quality Management ensures transfer points are located so their use does not compromise segregation and defines the practices needed to minimise the risk of product contamination; Operations Management ensures those practices are applied. Where cleaning or disinfection forms part of them, the detailed hygiene requirements are governed by the Housekeeping & Hygiene in High-Risk and High-Care Zones Procedure.

Apply additional controls where high-care barriers are absent

For high-care areas, physical barriers are the preferred method of separation from other parts of the site. Technical / Quality Management defines the segregation controls and Operations Management maintains the operational routes and controls for routine production, taking account of the same core factors used for high-risk segregation: product and material flow, packaging, equipment, personnel, chemicals, waste, air flow, air quality and utilities, including drains.

Where physical barriers are not in place, the procedure requires a documented cross-contamination risk assessment and additional validated protection. Technical / Quality Management defines and validates effective processes to protect products from contamination and also defines and validates the changeover from low-risk to high-care. Operations Management applies the validated processes and ensures the required changeover is completed before high-care production begins.

Where cleaning, disinfection or protective-clothing changes form part of the changeover, their detailed controls are provided through the relevant high-risk and high-care hygiene and protective-clothing procedures.

Base ambient high-care controls on documented pathogen risk assessment

For ambient high-care areas, a documented pathogen cross-contamination risk assessment provides the basis for determining the controls needed to protect final product from microbiological contamination. Technical / Quality Management considers raw materials and products; the flow of raw materials, packaging, products, equipment, personnel and waste; air flow and air quality; and the provision and location of utilities, including drains.

The completed assessment is used to define effective protective processes, which Operations Management applies during production. Depending on the microbiological contamination risk identified, these may include segregation, management of process flow or other appropriate controls. Detailed cleaning, disinfection and process-flow requirements remain governed by the supporting housekeeping, hygiene and layout procedures.

Separate technical responsibility from routine operational control

Senior Management provides the resources, supporting infrastructure and organisational arrangements needed for segregation, risk assessment and validation. Technical / Quality Management is responsible for the technical definition of segregation controls, high-risk transfer-point requirements, the required risk assessments and, where high-care barriers are absent, validation of protective processes and the low-risk-to-high-care changeover.

Site Management ensures identified pathogen control steps are shown on the current site map. Operations Management maintains defined routes and segregation controls during routine production and applies the required high-risk practices, validated high-care processes and ambient high-care controls. All Employees comply with the segregation, movement and contamination-control requirements relevant to their work.

Preserve evidence of mapping, risk assessment and validation

Records generated through the procedure may include site map records identifying pathogen control steps, high-care cross-contamination risk assessments where physical barriers are not in place, validation records for the associated protective processes, and ambient high-care pathogen cross-contamination risk assessments. The procedure also requires personnel involved in identifying, assessing, defining, validating, implementing, maintaining or applying these controls to be trained in the requirements relevant to their activities, with training delivery and record control managed through the Training & Competence Procedure.