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.
During PQ process, the package of the product and loading mode of the product should be specified; Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.
During PQ process, the package of the product and loading mode of the product should be specified; Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.
In general, MPQ and PPQ are performed simultaneously.If PPQ is performed in parallel with at least three MPQ runs, then a minimum of one additional PPQ run shall be performed using the full cycle process specification. Physical PQ (PPQ) shall demonstrate that the specified acceptance criteria are met throughout the load for the duration of the proposed routine process specification.
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
1.Process Equivalence?Ethylene oxide sterilization equipment that delivers the same process parameters, having undergone IQ and OQ, shall be qualified either.
2. in the same manner as the original chamber, or using a reduced MPQ that demonstrates the delivery of the required level of microbiological lethality and PPQ to demonstrate temperature and humidity uniformity of the load and control by the production chamber. The rationale for this reduced qualification shall be recorded and documented.
3. The influence of different geographical locations on the product or load properties shall be determined.
4. Process equivalence is a method used to demonstrate that the same validated sterilization process is delivered by two or more pieces or sets of Ethylene oxide sterilization equipment. It does not require that the equipment be physically identical. Even if the parameters delivered by the equipment are not statistically identical, the processes delivered can still be equivalent if they are all capable of running the process within the defined, validated process limits
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.
IF YOU WANT TO KNOW MORE
फोन:+८६१९९७५२५८६०३
इमेल:hayley@hzbocon.com
स्थानीय साइट: कोठा 1202, Caitong Zhongxin, Xiasha जिल्ला, Hangzhou शहर, Zhejiang प्रान्त, चीन
वेबसाइट:hzbocon.comzjbocon.com