cleanroom
페이지 정보
본문
Intro to Cleanroom Requirements for Pharmaceuticals
Cleanrooms are used in a wide variety of industries all around the world. Various types of cleanrooms have specific purposes, but all of them follow strict guidelines to maximize the effectiveness of such complex structures.
What is a cleanroom in pharmaceuticals?
According to PharmTech, “a cleanroom can be defined as an environment where the supply, distribution, and filtration of clean air” are appropriately regulated to meet the standards of government authorities.
In general, cleanrooms are important because they help protect manufactured products from contamination. More specifically, cleanroom requirements for pharmaceuticals are meticulously designed for the commercial survival of a successful product.
This video will help you understand the protocols of a cleanroom that ensure the best quality control, the fundamentals of cleanroom design, and the planning required.
@SHIFULLA4445 : Very nice idea
@troygamblejr8974 : Strict. But necessary!
Cleanroom Training Video
Description
@amandas.6500 : Funny, and informative! Thank you!
@rubiyeverino6415 : I have a doubt. The cleanroom coverall for ISO 6 needs to be sterile? If i get a reusable one and the material is resistent to heat, can i strilize the coverall?
@Kupferonkel : Keep in mind before critisizing: This is for electronics and computer industry, NOT pharmaceutical industries.
@joelchambileon627 : Exelente video gracias muchas gracias ;)
@liisbethhaurum9874 : Over all a great video. but with some small mistakes. No hands on the outside of the cleanroom suit. Also do not take off face mask and hairnet before you have reached the area without the cleanroom suits.
Aseptic Gowning for the Cleanroom
One of the primary safeguards that life science companies use to help prevent contamination in cleanroom operations is Gowning. Gowning is basically putting on clothing -- in this case layers of specially designed garments, covers, masks and gloves -- that isolates your body from the clean room environment.
Gowning is more involved than just slipping on a coverall and going to work. Gowning is itself a process, with carefully sequenced steps to ensure that your body is fully covered, and that the protective garb remains free of contamination.
In this video, we'll demonstrate the top-down approach for both general and aseptic gowning.
Practice using our free Sterile Gowning Game: https://www.ncbionetwork.org/educational-resources/elearning/sterile-gowning-procedures
@fuzzballfoxonionring6729 : I love how the dangers of violating cleanroom protocols are "it'll cost us loads of money!"
@serymoler3791 : Excellent!!! My only question is that between 12:42 to 12:52 the new (second) right sterile glove is resting on the outer surface of the inner plastic wrap that was touched early (12:38-1240) by the first (previous) right glove. Maybe he should have just lifted up out of the the inner plastic wrap at 12:38. Any thought?
@akampuliratalent7001 : I have just loved how elaborate it is
@wingcwan : is there any requirement for the grade C gown prior enter the aseptic area? especially bio burden?
@angie565656 : Thank you for this video cause I can’t remember the sequence of the steps in the order
Cleanrooms are used in a wide variety of industries all around the world. Various types of cleanrooms have specific purposes, but all of them follow strict guidelines to maximize the effectiveness of such complex structures.
What is a cleanroom in pharmaceuticals?
According to PharmTech, “a cleanroom can be defined as an environment where the supply, distribution, and filtration of clean air” are appropriately regulated to meet the standards of government authorities.
In general, cleanrooms are important because they help protect manufactured products from contamination. More specifically, cleanroom requirements for pharmaceuticals are meticulously designed for the commercial survival of a successful product.
This video will help you understand the protocols of a cleanroom that ensure the best quality control, the fundamentals of cleanroom design, and the planning required.
@SHIFULLA4445 : Very nice idea
@troygamblejr8974 : Strict. But necessary!
Cleanroom Training Video
Description
@amandas.6500 : Funny, and informative! Thank you!
@rubiyeverino6415 : I have a doubt. The cleanroom coverall for ISO 6 needs to be sterile? If i get a reusable one and the material is resistent to heat, can i strilize the coverall?
@Kupferonkel : Keep in mind before critisizing: This is for electronics and computer industry, NOT pharmaceutical industries.
@joelchambileon627 : Exelente video gracias muchas gracias ;)
@liisbethhaurum9874 : Over all a great video. but with some small mistakes. No hands on the outside of the cleanroom suit. Also do not take off face mask and hairnet before you have reached the area without the cleanroom suits.
Aseptic Gowning for the Cleanroom
One of the primary safeguards that life science companies use to help prevent contamination in cleanroom operations is Gowning. Gowning is basically putting on clothing -- in this case layers of specially designed garments, covers, masks and gloves -- that isolates your body from the clean room environment.
Gowning is more involved than just slipping on a coverall and going to work. Gowning is itself a process, with carefully sequenced steps to ensure that your body is fully covered, and that the protective garb remains free of contamination.
In this video, we'll demonstrate the top-down approach for both general and aseptic gowning.
Practice using our free Sterile Gowning Game: https://www.ncbionetwork.org/educational-resources/elearning/sterile-gowning-procedures
@fuzzballfoxonionring6729 : I love how the dangers of violating cleanroom protocols are "it'll cost us loads of money!"
@serymoler3791 : Excellent!!! My only question is that between 12:42 to 12:52 the new (second) right sterile glove is resting on the outer surface of the inner plastic wrap that was touched early (12:38-1240) by the first (previous) right glove. Maybe he should have just lifted up out of the the inner plastic wrap at 12:38. Any thought?
@akampuliratalent7001 : I have just loved how elaborate it is
@wingcwan : is there any requirement for the grade C gown prior enter the aseptic area? especially bio burden?
@angie565656 : Thank you for this video cause I can’t remember the sequence of the steps in the order
... 
댓글목록
등록된 댓글이 없습니다.
