USA – 18 March 2015 – Experchem has expanded into LC-MS to extract and identify unknowns from impurity profiles, and they will also provide the new potential known standard for future quantifications.
New equipment purchases, such as Fraction Collector and Lyophilizer, have enabled Experchem to collect new potential impurities to an amount that would make it possible for clients to have a standard for future assays.
The USP requirement for verification of compendial procedures is not only limited to methods that have not been performed at a new contract services laboratory, but is also a requirement that clients revisit method verifications if excipients or any other raw materials have changed from its suppliers. Experchem can perform an assessment and issue a subsequent protocol and perform testing.
Experchem has the expertise and knowledge to design a process validation for finished products from tableting to creams and ointments to packaging, and as well to provide in-process testing as required by way of protocol.
Cleaning validation is a procedure that uses Total Organic Carbon and Microbiological Testing to confirm that cleaning procedures established in a company are effective for the removal of any surface contaminants. This is necessary not only for new equipment, but existing equipment for testing consecutive batches. Experchem will perform testing with adherence to protocol based on limits that can be established through our R&D/Validation group depending on the ingredients and active within a product. Experchem will determine the limits of detection, as well as the limit of quantitation.
Water testing is another service Experchem offers. Water for production in a pharmaceutical environment is one of the most essential components. Water is not only used for cleaning of surfaces, but is it also used as an ingredient in production. Experchem can test water to all of the Pharmacopeia testing requirements. Since it is such a critical constituent of a production system, Experchem can establish a protocol and procedures for qualification and validation of water systems.
Experchem can provide an assessment of the ingredients in the formulation to determine the extent of testing needed for each market in terms of product safety testing for cosmetics. The typical testing that is required is Microbiological and Heavy Metals testing for all cosmetics in each market. This is something that is a standard test and done regularly at Experchem.
Microbiological testing has a requirements for sterility and endotoxin for injectable products. Experchem recently expanded its facility to include capability for sterility testing where all testing is now done in-house by qualified professionals.
Harmful bacteria and fungi can contaminate raw materials, production facilities, and branded products. Regulatory expectations include accurate identification of environmental isolates to support active environmental monitoring programs within pharmaceutical manufacturing environments as part of cGMP, and to implement accurate Corrective and Preventive Actions (CAPAs) for products and processes to reduce the risk of contamination. Experchem recommends a comprehensive consultation with an in-house Quality and Regulatory Specialist to assist with any testing and consulting requirements.
Media Contact
Company Name: Experchem Laboratories Inc.
Contact Person: Heather Kovensky
Email: Send Email
Phone: 416-665-2134, Toll free: 1-(866) 202-6447, Fax: 416-665-9251
Address:1111 Flint Rd., Unit 36 Downsview
State: Ontario
Country: United States
Website: http://experchemlab.com
Source: www.abnewswire.com
