Pharmacy Solution Set Siemens Pharmacy Solution is a bundled offering of products, systems, technologies, programs, and services that are specifically designed to help organizations meet the environmental requirements of USP 795, 797, and 800. Our solution is built with flexibility in mind, allowing us to assemble a customized solution that meets each customer's unique requirements based on their current level of compliance.
Pharmacy Solution Set Matrix USP 795 Matrix USP-NF Chapter 795 Requirement Evaluation Engineered Services & Solutions Environmental Controls Assessment of current environment Design, installation, and commissioning of room controls for the compounding area to achieve desired temperature and humidity levels Any activity that may result in airborne contamination (powder) must be performed in a containment ventilated enclosure (CVE).
Pharmacy Solution Set Matrix USP-NF Chapter 795 Requirement Evaluation Controlled Storage Areas Compounded Nonsterile Preparations (CNSPs) may be stored under different storage conditions before they are used.
Pharmacy Solution Set Matrix USP 797 Matrix USP-NF Chapter 797 Requirement Evaluation Engineered Services & Solutions Environmental Controls Assessment of current environment: Design, installation, and commissioning of (enhanced) room controls for the buffer and anteroom areas to achieve the desired airborne particle count, air changes per hour (ACPH), D/P, temperature, and humidity levels Primary Engineering Controls (PECs) All Compounded Sterile Preparations (CSPs) must be prepared in an ISO Cl
Pharmacy Solution Set Matrix USP-NF Chapter 797 Requirement Evaluation Engineered Services & Solutions Security Assessment of security and access control Secure access into the controlled area via: o Card access Access of personnel to controlled areas must be restricted. The PEC must be located in a controlled-access buffer area. When designing the facility, hands-free access doors are preferred.
Pharmacy Solution Set Matrix USP-NF Chapter 797 Requirement Evaluation Engineered Services & Solutions Environmental Monitoring (of Room) Assessment of environment Design, installation, and commissioning of (enhanced) room controls for the buffer and anteroom areas to achieve the desired ACPH, D/P, temperature, and humidity levels An ISO Class 7 buffer or ante-area supplied with HEPA-filtered air must have a minimum of 30 ACPH. A minimum D/P of 0.
Pharmacy Solution Set Matrix USP-NF Chapter 797 Requirement Evaluation Engineered Services & Solutions Controlled Storage Areas Assessment of storage areas Data integration of storage area and refrigerators and freezers into Desigo CC for monitoring, documenting, and alarming CSPs may be stored under different storage conditions before they are used.
Pharmacy Solution Set Matrix USP 800 Matrix USP-NF Chapter 800 Requirement Evaluation Engineered Services & Solutions Environmental Controls Assessment of current environment Design, installation, and commissioning of (enhanced) room controls for the buffer and anteroom areas to achieve desired airborne particle count, ACPH, D/P, temperature, and humidity levels Containment Primary Engineering Controls (C-PECs) All sterile and non-sterile hazardous drugs (HDs) as defined by NIOSH 2 must be compou
Pharmacy Solution Set Matrix USP-NF Chapter 800 Requirement Evaluation Engineered Services & Solutions Building System Information Management Service Solutions Environmental Controls, continued See previous page See previous page See previous page See previous page Containment Secondary Engineering Controls (C-SEC) C-PECs must be located within a C-SEC (buffer area or C-SCA) that meets these requirements: Externally vented through HEPA filters Physically separated D/P between -0.
Pharmacy Solution Set Matrix USP-NF Chapter 800 Requirement Evaluation Engineered Services & Solutions Security Assessment of security and access control for compounding and storage areas Secure access into the controlled area via: o Card access C-PECs must be located in an area that has restricted access. Access to areas where HDs are handled must be restricted to authorized personnel. When designing the facility, hands-free access doors are preferred.
Pharmacy Solution Set Matrix USP-NF Chapter 800 Requirement Evaluation Engineered Services & Solutions Environmental Monitoring (of Room) Assessment of environment Design, installation, and commissioning of (enhanced) room controls for the buffer and anteroom areas to achieve the desired ACPH, D/P, temperature, and humidity levels ISO Class 7 buffer or ante-area supplied with HEPA-filtered air must have: Minimum of 30 ACPH D/P of -0.01 to -0.
Pharmacy Solution Set Matrix USP-NF Chapter 800 Requirement Evaluation Engineered Services & Solutions Building System Information Management Controlled Storage Areas Assessment of storage area Data integration of refrigerators and freezers into Desigo CC for monitoring, documenting, and alarming Building automation system collects trend data and alarm statuses from integrated equipment.
Pharmacy Solution Set Matrix USP-NF Chapter 800 Requirement Evaluation Standard Operating Procedures The compounding facility must establish and follow written standard operating procedures (SOPs) designed to ensure the quality of the CSPs.
Pharmacy Solution Set Matrix Example Configurations – USP 795 Requirements based on: • USP 795: Pharmaceutical Compounding – Nonsterile Preparations (Proposed Revision: March 2018) • USP 797: Pharmaceutical Compounding – Sterile Preparations (Proposed Revision: July 2018) • USP 800: Hazardous Drugs – Handling in Healthcare Settings (Proposed Revision: February 2016) A6V11517837 Rev 1 September 2018 Page 14 of 17
Pharmacy Solution Set Matrix Example Configurations – USP 797 Requirements based on: • USP 795: Pharmaceutical Compounding – Nonsterile Preparations (Proposed Revision: March 2018) • USP 797: Pharmaceutical Compounding – Sterile Preparations (Proposed Revision: July 2018) • USP 800: Hazardous Drugs – Handling in Healthcare Settings (Proposed Revision: February 2016) A6V11517837 Rev 1 September 2018 Page 15 of 17
Pharmacy Solution Set Matrix Example Configurations – USP 800 Requirements based on: • USP 795: Pharmaceutical Compounding – Nonsterile Preparations (Proposed Revision: March 2018) • USP 797: Pharmaceutical Compounding – Sterile Preparations (Proposed Revision: July 2018) • USP 800: Hazardous Drugs – Handling in Healthcare Settings (Proposed Revision: February 2016) A6V11517837 Rev 1 September 2018 Page 16 of 17
Pharmacy Solution Set Matrix Example Configuration – USP 797 and 800 Requirements based on: • USP 795: Pharmaceutical Compounding – Nonsterile Preparations (Proposed Revision: March 2018) • USP 797: Pharmaceutical Compounding – Sterile Preparations (Proposed Revision: July 2018) • USP 800: Hazardous Drugs – Handling in Healthcare Settings (Proposed Revision: February 2016) A6V11517837 Rev 1 September 2018 Page 17 of 17
