Friday, January 30, 2009

AUTOCLAVE VALIDATION PROTOCOL

Validation of the Autoclave is classified into the following
1.0 OQ – Operational Qualification
2.0 PQ – Performance Qualification
The validation is being taken up to cater to the new requirements of the GMP. Since it is already in use only OQ and PQ will be considered.
VALIDATION TEAM:


[untitled13.bmp]

OPERATIONAL QUALIFICATION PROTOCOL (OQ)
1.0 PURPOSE :
To demonstrate and document that the operations
of the Autoclave take place as specified .
2.0 SCOPE :
Autoclave xxxxx will be qualified to meet OQ.
3.0 RESPONSIBILITY :
Microbiologist, Manager Q.C
4.0 PROCEDURE :
This should be performed by external agency like IIME.
4.1 Verify the following as per instrument operating procedure and calibration certificate kept in place before validation.
4.1.1 : Temperature display of Autoclave.
4.1.2 : Compound pressure gauge of Autoclave.
Acceptance criteria :
All calibration data found to be within the acceptable norms of calibration certificate.
4.2 Calibration of Thermocouples :
Calibrate all the thermocouples of data logger before and after the validation using standard thermometer and also made available party’s calibration certificates.
Acceptance criteria:
The variation between the temperature of thermocouples and the standard thermometer found to be within the acceptance criteria.
4.3 Heat Distribution Studies
Carry out heat distribution studies by using a multi-point data logger and maintain holding time for 15 minutes at 15 lbs. by fixing all the 12 probes as per diagram-1. Record the temperature and lag time of each probe as per Annexure –1 & 2.
Acceptance criteria
All probes must reach temperature 121-124°C and pressure must be within 15 to 18 lbs for 15min cycle.
Diagram-1

Probe No.1 to 12 inside the chamber

Load Pattern
Maximum Load
Load with all the glassware and media filled upto 70%, of the chamber and the details are as follows.
Test-1 : 250ml Conical flasks = 12 Nos with media, 13 Nos without media, 500ml Conical flasks with media = 4nos, 1000ml Conical flasks with media =4nos, Pipette10ml=10nos,Pipette 2ml=10nos, Pipette 5ml=10nos, Pipette 1ml = 10nos,100ml
bottles=20nos ,Filtering unit=10nos, Test tubes =25nos
Minimum Load
Load with all the glassware and media required for a day’s analysis (average).
250ml Conical flasks with media = 6nos, 500ml Conical flask with media – 3 nos., 1000ml Conical flask - 1 Pipette 10ml= 10nos, Pipette 2ml= 10nos, Pipette 5ml= 10nos, Pipette 1ml=10nos, Bottles=10nos, Test tubes - 25nos.
Record the temperature and lag time and tabulate as per annexure 1.

PERFORMANCE QUALIFICATION PROTOCOL (PQ)
1.0 PURPOSE :
To provide a performance qualification protocol for Autoclave.
2.0 SCOPE :
Specified to Autoclave xxxxx.
3.0 RESPONSIBILITY :
Microbiologist, Manager Q.C
4.0 PROCEDURE :
4.1 Heat Penetration Studies
Carry out the heat penetration studies by using a multi point data logger for the following loads mentioned. Record the temperature and lag time if any as per annexure 1 and 2.
Acceptance criteria:
All 12 probes must reach temperature 121°C to 124°C and pressure must be within 15 to 18 lbs. for 15 min cycle.
4.2 Microbial limit test :
Incubate the sterilised media flask or tubes from any one Maximum and Minimum load of heat penetration studies and observe for nutritive properties. Bacteria: 30 – 35 °C for 72 hrs, Fungi : 20 – 25°C for 120 hrs
Acceptance criteria:
No microbial growth should be observed i.e. Negative control and Nutritive properties of media must pass
4.3 Microbial challenge test :
Keep ampoules containing spores suspension of Bacillus stearothermophilus 106 ­ population at various location of the autoclave along with probes and maintain the sterilisation temperature at 15psi and 121°C during the heat penetration studies, once on the maximum load.
Acceptance criteria:
Autoclaved ampoules containing Bacillus stearothermophilus spores suspension ampoules should not show any colour change after five days of incubation.
5.0 DOCUMENTATION :
5.1
Master Instrument used for validation of autoclave
Institutes name and address carrying out calibration.
Standard calibrating instrument name and number.
Instrument certified against (Instrument of national or international standards)
Date of calibration and validity period of calibration.
Training certificate of persons (External agency) carrying out validation.
6.2 Autoclave being calibrated :
All temperature readings for autoclave being validated should be collected from the approved external agency like IIME.
Validation report with observed any error, statement of calibration and next validation due.
7.0 FREQUENCY :
Once in a year until and unless no change in autoclave. In case of any change, the autoclave must be revalidated

[untitled15.bmp]

[untitled16.bmp]

8.0
CONCLUSION : Finally conclusion should be drawn based on the results of above tests and documented.


[untitled17.bmp]

53 comments:

Unknown said...

Hi there. Nice blog. You have shared useful information. Keep up the good work! This blog is really interesting and gives good details. autoclaves, medical autoclave.

Unknown said...

Hi there. Nice blog. You have shared useful information. Keep up the good work! This blog is really interesting and gives good details. portable suction machine, surgical instruments.

Unknown said...

Hiiiiii, very informative blog.This is really helpful for everyone.

Thank you so much...

Autoclaves India

Roch said...

Manufacturers, Exporters, Suppliers of Autoclave Sterilizer, Laboratory Equipments, Lab Equipment, Medical Autoclave, Industrial Oven, Bod Incubator Bioreactors, Growth Chambers for Lab, Industry and Research Organization.

Roch said...

Roch Mechatronics is Manufacture, Exporter, Supplier of Laboratory and scientific Equipments including Autoclave, Incubators, Environment Growth Chamber, Stability Equipment, Fermenters and various other equipment which are used all over the World in all major laboratories, hospitals and scientific research centers.

Unknown said...

I really loved reading your blog. It was very well authored and easy to understand. Unlike other blogs, I have read which are really not good like this. Thanks a lot! Heat Exchangers || Columns || Mixers

Unknown said...

I like the valuable information you provide in your blog. I will bookmark your blog and check again here frequently. I'm quite certain I will learn many new stuff right here! Best of luck for the next! Thank you for share. Blenders || Autoclaves || Pressure Vessels

Unknown said...

Very good work on such topic. When I started to read blog I was occupied with the best way you current such great topic. By the way in which might you please publish extra article on such topic? I really respect it. Pressurized Equipment || Non Pressurized Equipment || Storage Tanks

VENKATESH KAMMELA said...

how can we justify thermocouple location in the autoclave and based on chamber volume how can we calculate the thermocouples location for validation.

Unknown said...

What Is revalidation Cycle Load Patarn
Each Load 1 Cycle Or 3 Cycle
Boviedick is required or not
Empty
Half Load
Full Load
Porous
Product Load Min Max

Unknown said...
This comment has been removed by the author.
Unknown said...

I am associated with autoclave products and nice to see this informative blog that how can these products are helpfull in medical field. autoclave manufacturer

Oracle Equipments said...

I am associated with medical equipments and nice to see this informative blog. Thank you...



autoclave manufacturer

Oracle Equipments said...

We have marked a distinctive niche in the market by providing Hot Air Oven which is relevant in food and medical industry for sterilization. This equipment is developed at our most modern manufacturing unit using best class components in conformity with set industry norms. The offered gamut of Hot Air Oven is highly recognized for sturdy construction, optimum performance, power efficiency, perfect functionality and reliability. In order to ensure quality, this oven is sternly tested on different parameters.


autoclave manufacturer

Oracle Equipments said...

We have been salt spray chamber manufacturers and suppliers high performing arts Salt Spray Chambers that’s wide used for hanging sample in pharmaceutical, chemical and different allied industries. These Salt Spray Chambers are manufactured in compliance with latest trade standards using supreme quality parts beneath the observation of our experts. Oracle Salt Spray Chambers Manufacturers are offered at market-competitive costs.


Unknown said...

Good it's helpful for my study in autoclave validation. Thanks u.

Unknown said...

We provide Cartridge Heaters at very tight tolerances, low prices and fast Delivery. See your design, get a quote or purchase from the web.

Unknown said...

Good Blog !!
Great information about autoclaves Protocols
this will really helpful for the users of Autoclaves and Sterilizer.

For Medical Equipment, Visit - www.tancolabproducts.com

Unknown said...

please could you help answering me
revalidation should contain 3 cycles of heat distribution and 3 cycles of heat penetration from each load max and min loads ????

Chris Maughan said...
This comment has been removed by the author.
Chris Maughan said...

If anyone has any questions regarding Autoclave Validation, I would be happy to help. We perform autoclave validation across Europe to International standards working with Porous and Fluids loads for the pharmaceutical and biotechnology sectors.
If you have any specific questions regarding autoclave validation, please feel free to visit www.thermalcompliance.co.uk and you can chat to one of our engineers via Live Chat.

DIAC said...

DIAC providing winter training in PLC SCADA, Robotics, Embedded Systems and registration started few seats are left. So, what are you waiting for book your seat @ +91-9953489987, +91-9818293887.

Kerrthika K said...

More impressive,useful blog for us !thanks for sharing..
Informatica Training in Chennai
Informatica Training center in Chennai
Blockchain courses in Chennai
Hadoop administration in Chennai
Ionic training course
Ionic Training in Chennai 
IoT Training in Chennai

sasi said...

I have to agree with everything in this post. Thanks for the useful sharing information.
Data Science Training in anna nagar
Data Science Course in Chennai
PHP Training in Chennai
Ethical Hacking Course in Tnagar
Data Science Training in T Nagar
Data Science Training in OMR
Salesforce Training in Chennai
selenium training in OMR

Mr Naveen said...

Get safe precaution during the COVID-19 Pandemic stay at home and take all necessary precaution like keep wash your hand with soap, use sanitize again and again don't go outside and keep maintaining social distancing. Online Medical Store in India
If you want any medicine you can find online medical equipment supplier who can avail.
Local Medical Supplier
Medical device supplier

guest post sites
Get the blog posting sites from these guest blogger who provide free guest post sites
guest blogger provides list of guest blogging

saniyaa said...

An obligation of appreciation is all together to share the data, continue doing magnificent... I really savored the experience of exploring your site. incredible resource... environmental chamber price

sushmi reddy said...

I like this one...more helpful information provided here.I am quite sure I will learn much new stuff right here! Good luck for the next!
Oracle Training | Online Course | Certification in chennai | Oracle Training | Online Course | Certification in bangalore | Oracle Training | Online Course | Certification in hyderabad | Oracle Training | Online Course | Certification in pune | Oracle Training | Online Course | Certification in coimbatore

Cate said...

High temperature can kill many bacteria, here is a high temperature environment chamber.

borav said...

The following time I read a blog, I trust that it doesn't bomb me similarly as much as this specific one. That is to say, I realize it was my decision to peruse, regardless I really trusted you would presumably have something valuable to discuss. All I hear is a lot of crying about something you could fix on the off chance that you were not very bustling searching for consideration.
evrmag

Unknown said...


It's difficult to find experienced individuals about this subject, yet you seem like you hear what you're saying! Much obliged


best interiors

PackersMoving said...

You have written an excellent article. After reading your article, people like us, and we get a lot of information. Please keep writing such articles in the feature, and I wish you all the best for sharing this excellent article with us.
Chota hathi on rent in Delhi
Chota hathi on rent in Ghaziabad
Chota hathi on rent in Gurgaon
Chota hathi on rent in Faridabad
Chota hathi on rent in Noida
Chota hathi on rent in Mumbai
Packers And Movers App
Rehousing Packers And Movers
Rehousing Packers

Medical equipment manufacturer in Delhi said...

Thanks for writing such a great article on medical equipment, we are also one of the best India's manufacturers and suppliers of the below equipment. that is
Dental UV chambers manufacturer in Delhi, Autoclave Cooker type manufacturer in Delhi, Dressing drum manufacturers in Delhi, Holloware manufacturers in Delhi, and Height scale manufacturers In Delhi

Vikesh sharma said...

The household items or your office furniture are guaranteed to move safely from your old to your new home or office. Movers and packers instinct in all situations sets us apart from the competition.
Packers and movers in Sector 27
Packers and movers in Sector 63
Packers and movers in Sector 75
Packers and movers in Sector 76
Packers and movers in Gamma
Packers and movers in Jagat Farm
Packers and movers in Sector 150

Reload Digital said...

From individual storage boxes to storage rooms for an entire household articles in Delhi.
Packers and movers in Rohini Sector 3
Packers and movers in Rohini Sector 6
Packers and movers in Rohini Sector 16
Packers and movers in Rohini Sector 24
Packers and movers in Rohini Sector 20
Packers and movers in East Delhi
Packers and movers in West Delhi
Packers and movers in North Delhi
Packers and movers in New Delhi
Packers and movers in Aya Nagar

Hensonjebajose said...

Ho nice blog. Is there any limit between the probe

RAM PRAKASH said...

thanx for sharing for this information..

Bursting Strength Tester
Salt Spray Chamber
Melt Flow Index

Payal Mishra said...

Thanks for Sharing Information. Get details of
Packers and Movers from Mahipalpur to Hauz Khas

Ujjawal Packers and Movers said...

Movers and Packers Quotation
Packers and Movers Ranchi
Packers and Movers Patna
Packers and Movers Surat
Packers and Movers Pune
Packers and Movers Shimla
Packers and Movers Jodhpur

wowcigarette said...

Thank you so much. Gemstones from crystal shops can be an addition to your routine, but not a substitute for a doctor’s orders nor a be-all, end-all solution.

Hospital Equipment said...

Altos Engineers is the Modular Operation Theatre Manufacturer, Supplier in India. We are providing complete turnkey solutions for Modular Operation Theater Equipments as per the latest guidelines. Air conditioning systems play a vital role in maintaining hygiene in operation theaters.
A modular operation theater is a facility within a hospital where surgical operations are performed in a sanitary environment. Altos Engineers is the Best Modular Operation Theater Manufacturer in India.

Anonymous said...

thanks for valuable information on AUTOCLAVE VALIDATION PROTOCOL, keep posting Java Training In Pune

laylacooper said...




Looking for the best dental equipment supplier in the UK? You've come to the right place. AHP dentals supply company based in UK. and They are leading suppliers of high quality dental products. Their focus is on making the lives of dentists easier by providing them with the best dental products available in UK. More details visit their website.

SHIVAM SHARMA said...

Useful post Thanks for sharing it that truly valuable knowledge about similar topic. Since the CCNA certification is acknowledged around the world, your work will be applicable practically everywhere you go. ccna classes in pune

Unknown said...

Thank you for sharing this valuable information! Your post was very informative and helpful. Keep up the great work! Test chamber

Varpar Furniture said...

Nice Blog...
Thanks For Sharing...
Best modular lab furniture in India

Packers and Movers in Delhi said...

Nice Post Follow this link
Truck Tempo on Rent in Rohtak

Vimal said...

Perfect and useful post Registered house shifting in Trivandrum and also best shifting company in thiruvanthapuram kerala

packers and movers in chennai said...

Good information
best packers & movers

schavan223 said...

Nice blog article that i have read today. Keep uploading these types of Articles regulerly.Also, refer Data Science Course in Kolhapur

Vijay Thomas said...

Nice article you sahred, contact Best Packers and Movers in Kochi and make your shift easy and safe

Tempo traveller hire said...

TEMPO TRAVELLER HIRE IN GURGAON

Fermenter Technologies said...

Such a great post I found it very helpful. Are you searching for high-quality Lab Scale Bioreactor in India? Look no further than Fermenter Technologies. We're a top supplier and manufacturer that offers reliable products and services to help you meet your Lab Scale Bioreactor needs. Contact us today to learn more….

Super Tech Engineer said...

Wow such a great post I found it very helpful. Are you searching for high-quality Super Sucker Machine in India? Look no further than Supertech engineers. We're a top supplier and manufacturer that offers reliable products and services to help you meet your Super Sucker Machine needs. Contact us today to learn more….

Pharmaceutical Validation Documentation Requirements

Pharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe fo...