Water Testing

Water analysis is an imperative quality control process in any pharmaceutical, biotech, nutraceutical, cosmetic, and medical device manufacturing business. We perform microbial and chemical water analysis here at Chromak Research to ensure that water meets the stringent standards necessary for the manufacturing process, as well as regulatory requirements.

Water used in manufacturing, formulation, and cleaning operations must meet high microbiological and chemical quality requirements. Poor water quality can compromise product safety, batch integrity, and regulatory approval.

Chromak Research has the full complement of water testing capabilities that are set up to detect microbial contamination, endotoxins, organic material, and heavy metals. We test all types of water including:

We conduct microbial enumeration tests in our lab to assess the total microbial load contained in water samples. We test for:

• Total aerobic microbial count (TAMC)
• Total yeast and mold count (TYMC)

This analysis ensures the water utilized for manufacturing and cleaning operations will not present a risk of contamination in final product.

Bacterial endotoxins, which occur most commonly in gram-negative bacteria, can be life-threatening if they are present in medical or injectable products. We use the Limulus Amebocyte Lysate (LAL) test to measure endotoxins in water and meet USP and FDA standards.

TOC analysis is a critical test that examines organic contamination in high-purity water systems. TOC measurement assists in:

Validation of cleaning procedures

Water system health evaluation

Meeting pharmacopeial standards for water employed in drug preparation

Chromak Research water sample heavy metal analysis examines and measures toxic substances such as lead, mercury, arsenic, and cadmium. Heavy metal regulation is vital for pharmaceutical GMP compliance and customer protection.

Burkholderia cepacia Complex is a collection of opportunistic pathogens with aqueous environmental tolerance. According to USP <60>, water employed in manufacturing, particularly in non-sterile aqueous-based products, is required to be tested for BCC contamination.

Focused testing by Chromak Research for BCC in line with USP <60> ensures product quality and patient safety.

Chromak Research performs all water analysis under cGMP (Current Good Manufacturing Practice) conditions in compliance with FDA, USP, and ICH regulations. Our laboratory maintains rigorous documentation, quality control, and validation processes to provide accurate results.

Our water testing ability is relied on by customers in these industries:

Maintain the quality and compliance of your water systems with Chromak Research’s full range of water testing. If you require microbial limits testing, endotoxin testing, or USP <60> Burkholderia cepacia testing, our competent staff stands ready to assist your quality assurance initiatives.