The container need not be filled to its normal fill volume. The fill volume must be controlled and monitored as performed during routine filling. Where partial fills are employed, the fill speed should follow the advice given in Section 7.7. Regardless of the actual fill volume, the process simulation should include a fill weight/volume adjustment using methods identical to those employed during production.
While the specific amount of medium utilized in a partial fill may not be critical, there are two general criteria. First, there must be enough medium in the container to contact all the container-closure seal surfaces when the container is inverted and swirled. Second, there must be enough medium in the container to allow for the detection of microbial growth.
The volume of headspace should be considered in the growth promoting capability of the media to support aerobic microorganisms (See Section 7.16).
在培养基能力成长促进中,应考虑顶空体积,以支撑需氧微生物(见 7.16)
7.13 Incubation Conditions
培养条件
Prior to incubation, filled APS units should be inverted or manipulated to ensure contact of the medium with all internal surfaces of the closure system before they are incubated. APS units should be incubated for a minimum of 14 days unless supported by another qualified duration/method. The temperature chosen should be based upon its ability to recover microorganisms normally found in the environment or in the product bioburden. A single incubation temperature in the range of 20-35°C may be used (6). Data should be available to show the suitability of the selected incubation temperature to support growth. The selected temperature should be controlled and monitored continuously throughout the incubation period.
(2)PDA TR22 第7.13培养条件“培养之前,灌装的APS单位应倒置或进行相关操作以确保培养基接触到所有密封系统内表面。(Prior to incubation, filled APS units should be inverted or manipulated to ensure contact of the medium with all internal surfaces of the closure system before they are incubated.)”