Detailed analysis of bacterial endotoxin test in door sterilization oven

The door opening sterilization oven is divided into two types: general type and self-purification and high efficiency type, which is characterized by front and rear door opening mode, inlet and outlet with high efficiency filter, internal heating air circulation, door opening interlock and other characteristics
.

Self-cleaning and high-efficiency types include advitive circulation wind type (side feed side return) and vertical laminar flow wind type (middle feed side return); The universal door door sterilization oven is divided into two types
: side feed side return and bottom feed middle return.

Clean type advish circulation air type foetal door sterilization oven, under the action of centrifugal fan, the hot air is sent into the box from one side of the high temperature high efficiency filter, returned through the other side, the oven after 20-30 minutes since the cycle of cleanliness can reach 100 levels (that is, containing particle size 0.
5um particles 3.
5 particles / l).


It is mainly used for the sterilization of antimicrobial glass bottles and 50~100ml infusion bottles, and can also be used
for other sterilization.

Clean vertical laminar flow air oven feeds hot air from the top high temperature high efficiency filter into the box and returns
from both sides through the bottom.

It is mainly used for the sterilization
of barrel appliances for raw material production.

Ordinary type door door sterilization oven, generally used for conventional drying and sterilization, can also be based on the requirements of the cleanliness of the working environment, some high cleanliness drying sterilization
.

The door opening sterilization oven will be completed at one time the working temperature, moisture discharge temperature, moisture discharge time, constant temperature time and shutdown temperature can be completed, and the control will automatically work in accordance with the set procedure after booting until the work is completed and automatically stopped
.

Bacterial endotoxin testing in open-door sterilization ovens: Verification Objectives: Confirm that the intended sterilization procedure can reduce endotoxins by 3 logs
after sterilization.

Verification of the design basis: The design of the scheme is based on the sterilization of SOPs in the door sterilization oven, the GMP guide for drugs 2011 and USP
.

Operation method and verification steps: carrier selection: 7mm × 14mm rectangular specifications, made of aluminum sheet, stainless steel sheet
.

Preparation of indicators: Take endotoxin indicators (content of 100,000EU/stick) and dissolve 10mL of water for the test to make an indicator solution
containing endotoxins of 10,000EU.

Add 0.
1ml of indicator solution containing endotoxin 10000EU/ml dropwise on each carrier, and then place the above carrier on the purification bench to air-dry the water
.

I.
1~I.
8 is a stainless steel carrier, and I.
9~I.
14 is an aluminum sheet carrier
.

I.
8 and I.
14 are used for positive controls
.

The position of the carrier is consistent with the position of the thermocouple, and the material of the carrier is consistent
with the object to be sterilized.