Model NO.:

D90A

Type:

Sterility Test

Material:

Plastic

Ethylene Oxide Sterilization:

Irradiation Sterilization

Quality Guarantee Period:

6 Months

Logo Printing:

Accept Customization

Finished Dosage Form:

Liquid

Precision:

Precision

Certification:

CE, MSDS

Computerized:

Accept Computerized

Customized:

Customized

Condition:

New

After-Sales Service:

Enginners Available to Serve Machinery on Line

Trademark:

Winteam

Transport Package:

Carton

Specification:

1450*610*1500mm

Origin:

China

HS Code:

3821000000

Product Description

products appearance	Light yellow, flat surface, no cracks, no visible impurities and bubbles
physicochemical property	PH acceptable, gel strength 500-750g/cm²
Sterility and water retention	30-35ºC,Culture for 5 days, no bacterial growth,Culture for 5 days, no bacterial growth, no obvious water loss phenomenon
Packing	Class A laminar flow production line automatic canning, to avoid the risk of personnel pollution
Growth experiment	Inoculate the corresponding strains 50-100CFU according to the pharmacopoeia, and the ratio of the mean number of colonies on the test solid medium to the mean number of colonies on the control medium should be within the range of 0.5-2, and the size of the colonies should be consistent with the colonies on the control medium

Item	Model	description	culture	usage
CP020028	D55A	PETRI DISH	TSA	Surface microbial sampling without disinfectant and antibiotic residues
CP020029	D55B	PETRI DISH	TSA with Lecithin and Tween 80	Surface microbial sampling of residual disinfectant
CP020030	D55C	PETRI DISH	TSA with Lecithin and Tween 80,Penicillin G	Sampling of surface microorganisms from residual penicillin antibiotics
CP020032	D55E	PETRI DISH	SDA	For fungal detection on surfaces
CP020033	D90A	PETRI DISH	TSA	Microbial detection of airborne settling bacteria and floating bacteria without disinfectant and antibiotic residues
CP020034	D90B	PETRI DISH	TSA with Lecithin and Tween 80	Microbial detection of airborne settling bacteria and floating bacteria in residual disinfectants
CP020035	D90C	PETRI DISH	TSA with Lecithin and Tween 80,Penicillin G	Microbial detection of airborne settling bacteria and floating bacteria with residual penicillin antibiotics
CP020037	D90E	PETRI DISH	SDA	For airborne fungal detection
CP020075	D90F	PETRI DISH	TSA with Cephalosporinase	Microbial detection of airborne sedimentation bacteria and floating bacteria with residual cephalosporin antibiotics
CP020109	D90G	PETRI DISH	EMB	Isolation and identification of Escherichia coli and Aerogenes
CP020110	D90H	PETRI DISH	NA	Generally used for bacterial culture, transfer, rejuvenation, bacterial enhancement
CP020116	D90R	PETRI DISH	R2A	For the determination of the total number of colonies in purified water

The collection collection incubator is carefully manufactured by forty processes, each in strict accordance with the ISO9001 quality system and ISO14001 environmental system requirements. 100% of the products passed the integrity test, achieving continuous improvement in quality traceability and quality. According to the testing requirements of different dosage forms and packaging forms, various cups, filter materials and matching needles were selected, and various collection incubators were designed and developed to meet various sterilization tests. need.

Product rinse sterility test
Combination product: Product rinse sterility test is only applicable to products with hollow tubes, such as infusion and infusion sets, which are not suitable for soaking and the fluid channel is marked as sterile, this method is easy to operate and requires modification of FTM media with liquid D rinse products, The eluate was membrane filtered and placed in FTM and SCDM. This method is usually not used.

Bulk drugs / biopharmaceuticals
Bulk drugs (API) have been sterilised according to USP 71 prior to release to the manufacturing process.

Bulk biologics are tested for sterility according to 21 CFR 610.12, which requires a medium (FTM) with sample test sizes listed in the document and a capacity of not less than 10 ml.10

Interpretation of sterility test results
Technicians must be trained in growth testing methods during the cultivation process. Growth is determined by observing a medium that is generally transparent and transparent with respect to the light source, and the turbid (turbid) area of the medium indicates the growth of microorganisms. Once growth is detected, the suspect container is tested to confirm that the turbidity present is due to microbes, not due to decomposition of the sample; sometimes, the sample becomes cloudy due to particle shedding or chemical reaction with the medium. After testing, return to the incubator for the remainder of the incubation period. Samples turbid in the medium were transferred and displayed for four days on the 14th day of the test.