Advice
As an external quality control laboratory, we are known for always making ourselves available to our clients, in order to provide solutions.
Because we understand the needs of releasing products to the market, we provide the analysis execution service in our facilities with the highest standards of rigor, professionalism and in the time agreed with our clients.
As an external quality control laboratory, we are known for always making ourselves available to our clients, in order to provide solutions.
Because we understand the needs of releasing products to the market, we provide the analysis execution service in our facilities with the highest standards of rigor, professionalism and in the time agreed with our clients.
Environmental monitoring
We provide our clients with the following services
Revision of the environmental monitoring program in classified areas in which manufacturing processes are carried out
Drafting and updating of standard operating procedures related to the environmental monitoring of critical and non critical areas.
Risk analysis that allows to provide support to the existing monitoring points or to generate reduction of the same ones that additionally impact on an optimization of existing resources and materials.
Training
Analytical methodologies validations
We provide our clients with the following services
Generation of protocols and reports of validation of microbiological methods (sterility analysis,hygienic control, bacterial endotoxin test, etc.) According to the harmonized alignments of the international pharmacopeias (USP,BP,JP)
Generation, revision and updating of the microbiological analytical techniques according to the validations carried out by the client.
Aseptic process validations
We provide our clients with the following services.
Aseptic filling process design depending on the facilities and the type of product.
Support during the initial validations processes as well as in subsequent validations due to non compliance or periodic revalidation.
Generation and revision of or documentation associated with Media Fill. In order to verify compliance with national and international recommendations.
Advice during the failure analysis stage.
Obtain updated infomation on inveronmenteal monitoring and technical advice in our E-BOOKS.
Obtain updated infomation on inveronmenteal monitoring and technical advice in our E-BOOKS.
Contact us
?? Argentina:
Buenos Aires. Argentina
Sargento Cabral 2431
Vicente López
CP 1605
Telf: +54 9 11 3027-3162
?? Paraguay Affiliate:
Asunción, Paraguay
Misiones 593 e/ Perú
CP 1102
Telf : 0972-104600
?? EEUU Affiliate:
Florida. EEUU
1101 Brickell Avenue South, Tower 8th Floor, Miami,
FL 33131
Telf: (305) 381- 1855
Email adress:
ventas@mikrobiol.com
Spesialists in environmental monitoring and technical advice.