Design, development and qualification of a microbiological challenge facility to assess the effectiveness of BFS aseptic processing
F Leo, P Poisson, CS Sinclair… - PDA Journal of …, 2005 - journal.pda.org
A programme of work has been initiated to further the understanding of the impact of the
environment surrounding a Blow/Fill/Seal (BFS) machine upon the microbiological quality of …
environment surrounding a Blow/Fill/Seal (BFS) machine upon the microbiological quality of …
[PDF][PDF] Performance of blow/fill/seal equipment under controlled airborne microbial challenges
CS Sinclair, A Tallentire - PDA Journal of Pharmaceutical …, 1995 - weilerengineering.com
Fundamental investigations have been carried out into the effectiveness of aseptic fill using
Blow/Fill/Seal machinery. Techniques have been developed to generate and to maintain …
Blow/Fill/Seal machinery. Techniques have been developed to generate and to maintain …
Environmental microbial challenges to an aseptic blow-fill-seal process—A practical study
DJ Jones, P Topping, J Sharp - PDA Journal of Pharmaceutical …, 1995 - journal.pda.org
A Blow-Fill-Seal machine, set to aseptically fill sterile liquid TSB medium into 20 ml plastic
containers, was subjected to a series of environmental microbial challenges in order to …
containers, was subjected to a series of environmental microbial challenges in order to …
[PDF][PDF] Airborne microbial challenges of Blow/Fill/Seal equipment: a case study.
A Bradley, SP Probert, CS Sinclair… - Journal of parenteral …, 1991 - weilerengineering.com
Controlled microbial challenges, comprising air-dispersed spores of Bacillus subtilis var
niger, have been generated within a containment room (around 54 m'in volume) housing a …
niger, have been generated within a containment room (around 54 m'in volume) housing a …
Airborne contamination during blow-fill-seal pharmaceutical production
W Whyte, W Matheis, M Dean-Netcher… - PDA Journal of …, 1998 - journal.pda.org
The routes of airborne contamination, during Blow-Fill-Seal (BFS) production, were studied
using tracer gas, particles and bacteria. The prevention of airborne contamination, by the air …
using tracer gas, particles and bacteria. The prevention of airborne contamination, by the air …
[HTML][HTML] Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
J Johnson, S Probst, T Palberg, P Gil… - BioPharm …, 2011 - biopharminternational.com
The control of the environment around biologics manufacturing has historically been a key
consideration for the design and operation of bioprocessing facilities to ensure product …
consideration for the design and operation of bioprocessing facilities to ensure product …
Evaluation of disinfecting procedures for aseptic transfer in hospital pharmacy departments
M Mehmi, LJ Marshall, PA Lambert… - PDA Journal of …, 2009 - journal.pda.org
Current practice in National Health Service (NHS) hospitals employs 70% Industrial
Methylated Spirit spray for surface disinfection of components required in Grade A …
Methylated Spirit spray for surface disinfection of components required in Grade A …
[PDF][PDF] Aseptic processing: A vision of the future
J Agalloco, JE Akers - Pharm. Technol, 2005 - alfresco-static-files.s3.amazonaws …
Continued technological improvement, beyond what is commonplace today, is the only real
way to achieve continued improvement in aseptic processing. s eptic processing is the met h …
way to achieve continued improvement in aseptic processing. s eptic processing is the met h …
Development of an advanced high speed aseptic filling system
M Deguchi, J Akers, S Yoshida… - PDA Journal of …, 2003 - journal.pda.org
A new pharmaceutical aseptic vial filling system has been developed based on isolator
technology that is also well suited to use in conventional clean rooms. The results of …
technology that is also well suited to use in conventional clean rooms. The results of …
Microbiological challenge of four protective devices for the reconstitution of cytotoxic agents
K De Prijck, E D'Haese… - Letters in applied …, 2008 - academic.oup.com
Aims: To evaluate the susceptibility to microbial contamination that occurs during simulated
handling of protective devices for the preparation of cytotoxic drug solutions. Methods and …
handling of protective devices for the preparation of cytotoxic drug solutions. Methods and …