AAMI ISO 13408-2:2018 pdf download – Aseptic processing of health care products

03-12-2022 comment

AAMI ISO 13408-2:2018 pdf download – Aseptic processing of health care products
6.1 General
The purpose of this activity is to define the entire sterilizing fltration process so that it is both safe and reproducible.
6.2 Risk management
6.2.1 The following additional requirements to ISO 13408-1:2008,5.2, and ISO 13408-1 :2008/Amd.1:2013 concerning risk management apply.
A risk assessment shall be performed during the selection of the filter and filtration equipment. The risk assessment shall include, but is not limited to the following:
a) effects of variables identified in 5.2.2;
b) the design of the sterilizing filtration system in terms of the incorporation of, and location within the system of particulate reduction or bioburden reduction filters, single or sterilizing filters in series, redundant sterlizing grade filters or parallel sterilizing grade filters;
c) the risk to the sterility of the fltration system when pre-use post-sterilization integrity testing (PUPSIT) is carried out;
d) the risks associated with filter reuse for the sterilizing fltration process for a given fluid.
6.2.3 Risk management shall include assessment and management of risks associated with the outsourcing of sterilization of critical sterile components, for example, where flters are purchased sterile.
For single use fltration systems this shall include an evaluation of the fllowing:
a) the supplier’s assembly design (including the filter user’s need for single, serial, redundant or parallel filter design), materials of construction, manufacturing and sterilization processes;
b) filter location, i.e. inside or outside of an isolator;
c) the ability to conduct a pre-use post-terilization integrity test (if required);
d) how the assembly performs in the filtration process for the fluid, including requirements for filter flushing or wetting;
e) maintenance of downstream sterility;
f) integrity testing of closed systems;
g) how the assembly impacts the filtered fluid.
6.2.6 Risk management shall be applied iteratively. The risk assessment shall be updated as necessary if the sterilizing fltration process changes during development and validation.
6.3 Process characterization
6.3.1 The process parameters and their tolerances shall be specified. These tolerances shall be based upon knowledge of the combination of process parameters yielding minimal acceptable microbial removal effectiveness. Processing within such process parameters shall routinely yield safe and functional sterile filtrate.
The establishment of tolerances for process parameters shall be based upon analyses of process variables (see Clause 8).
6.3.2 Means of controlling and monitoring the process variables shall be determined.
6.3.3 Any treatment of fluid that is required prior to exposure to the sterilizing filter to ensure effectiveness of the sterilizing flration process shall be specified (for example, the use of a bioburden reduction filter).
6.3.4 Following sterilizing filtration subsequent aseptic handling of sterile filtrate shall be as specified in ISO 13408-1.
6.4 Equipment characterization
6.4.1 The equipment to deliver the process in a safe manner within the parameters stipulated for the process variables shall be specified.
6.4.2 The specification shall include, but is not limited to a physical description of the equipment and necessary ancillary items, including materials of construction.
6.4.3 The selection of components for the filtration system and their interconnection and arrangement within the filtration system shall be documented and justified.

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