PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.
PQ should be carried out for each new process and/or product to be validated to demonstrate that the process complies with identified acceptance criteria and is capable of delivering the required SAL to the product.PQ consists of both microbiological and physical performance qualifications and is performed in the Ethylene oxide sterilization equipment used to sterilize the product.
喺 PQ 過程中，應該指定產品嘅包裝同產品嘅裝載模式；揀啲有代表性嘅產品或者材料，佢哋嘅包裝同材料組成可以覆蓋所有要殺菌嘅產品或者整個產品系列。
喺 PQ 過程中，應該指定產品嘅包裝同產品嘅裝載模式；揀啲有代表性嘅產品或者材料，佢哋嘅包裝同材料組成可以覆蓋所有要殺菌嘅產品或者整個產品系列。
一般嚟講， MPQ 同 PPQ 係同時進行。如果 PPQ 係同至少三次 MPQ 運行並行進行，噉就應該用全循環過程規格至少額外進行一次 PPQ 運行。物理 PQ （ PPQ ）應證明喺建議嘅常規工藝規格期間，喺整個負荷期間都符合指定嘅驗收準則。
PQ shall be performed on the introduction of new or modified products,packaging, load configuration, Ethylene oxide sterilization chamber or process parameters unless equivalence to a previously validated product, packaging, load configuration Ethylene oxide sterilization chambernt or process has been documented.
PQ verification Ethylene oxide sterilization chamber process
The process of PQ verification is generally as : perform a fractional cycle first, and test the sterility status of the product after
fractional
cycle sterilization; compare the EO resistance relationship between IPCD, EPCD and representative products (the expected result is EPCD > IPCD > Product,); Refer to ISO-11737-2 for the test requirements involved in the fractional cycle.
Perform half cycle to prove the reproducibility of the sterilization process and sterilization effect; If the overkill method is used, then there should be no positive IPCD during half-cycle.Positive EPCD during the half cycle are acceptable if have demonstrated greater resistance than the IPCD providing a
“
worst-case challenge
”
for routine processing.
The routine sterilization parameters are usually determined by the full cycle parameters, so residual challenges are generally done during the full cycle to determine the appropriate aeration time. Since the effectiveness of the sterilization process has been proven in fraction cycle and half cycles, the sterilization effect can be ensured by EPCD.
If, in any of these runs, sterility or product functionality requirements are not met, an investigation should be conducted to determine if additional qualification runs are necessary. If process parameters cannot be maintained within the defined limits, an investigation should be conducted. If modifications are made, additional runs must be necessary.
Annual PQ in Ethylene oxide sterilization chamber process
Review of PQ should assessment that the sterilization process remains valid for the designated product.Reduced MPQ/PPQ can be necessary in certain situations, e.g. to verify continued appropriateness of the resistance of the internal PCD in the product load to the resistance of the product bioburden, or, after a defined interval, to provide evidence that there has been no inadvertent change since the previous requalification study. This would typically include, minimally,one fractional or half cycle exposure including load temperature and humidity measurements. Fractional cycles in a developmental chamber can also be used to support a requalification program, but requalification of the production chamber should be performed in the production chamber.
Assessment of equivalence
工藝等效性？提供相同工藝參數嘅氧化乙烯殺菌設備，經過 智商 同 OQ，應該係合格嘅。
2. 以同原始室相同嘅方式，或者用降低嘅 MPQ 去證明提供所需水平嘅微生物殺傷力，同埋用 PPQ 去證明負荷同由生產室控制嘅溫度同濕度均勻性。呢個降低資格嘅理由應該記錄同記錄低。
3. 應確定唔同地理位置對產品或負荷性質嘅影響。
4. 工藝等效係一種用嚟證明同一個經過驗證嘅殺菌工藝係由兩件或以上嘅環氧乙烷殺菌設備提供嘅方法。佢唔需要啲設備喺物理上係一樣。即使設備所交付嘅參數喺統計上唔相同，如果佢哋全部都能夠喺定義咗嘅、經過驗證嘅過程限制之內執行過程，所交付嘅過程仍然可以係等效嘅
5. Process equivalence among multiple pieces of equipment is intended to minimize the amount of testing required to qualify the process. The sterilization process should be validated in one chamber. The remaining equipment can undergo reduced PQ if the remaining equipment has undergone installation qualification (IQ) and operational qualification (OQ) (see 9.2 and 9.3). Equivalence can also be used to reduce requalification of several pieces of equipment. The equipment used to deliver a sterilization process commonly consists of a chamber or room and ancillary control systems. Sterilization process equipment might be located within a given processing facility or among several facilities.This equipment can be used independently to deliver the same process conditions and could be exactly the same design or might differ in size or in the extent of ancillary equipment.
6. Process equivalence among multiple pieces of equipment is intended to minimize the amount of testing required to qualify the process. The sterilization process should be validated in one chamber. The remaining equipment can undergo reduced PQ if the remaining equipment has undergone installation qualification (IQ) and operational qualification (OQ) (see 9.2 and 9.3). Equivalence can also be used to reduce requalification of several pieces of equipment. The equipment used to deliver a sterilization process commonly consists of a chamber or room and ancillary control systems. Sterilization process equipment might be located within a given processing facility or among several facilities.This equipment can be used independently to deliver the same process conditions and could be exactly the same design or might differ in size or in the extent of ancillary equipment.
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