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معتمد ISO 17025

Microbiology Testing for Supplements, Cosmetics & Foods

Accurate microbiological testing to ensure product safety, regulatory compliance, and shelf stability.

Microbiology testing laboratory at Qalitex

Microbiology testing detects and quantifies microorganisms — including bacteria, yeast, mold, and pathogens — in consumer products to verify safety, support shelf-life claims, and meet regulatory requirements such as USP <61>/<62> and FDA 21 CFR Part 111.

Qalitex Laboratories specializes in microbiological testing services designed to verify product safety, extend shelf life, and support regulatory compliance. Our testing protocols follow USP <61> and <62>, AOAC guidelines, and FDA regulations, ensuring your products meet the strictest standards for microbial safety.

Microbial Limit Testing

Our comprehensive microbial limit tests detect and quantify total aerobic microbial counts (TAMC), total yeast and mold counts (TYMC), and specific objectionable organisms including E. coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa.

Pathogen Screening

Our pathogen screening covers Salmonella, Listeria monocytogenes, E. coli O157:H7, Clostridium, and other pathogens relevant to your product type. Early detection prevents product recalls and protects consumers.

Preservative Efficacy Testing (Challenge Testing)

Preservative efficacy testing (PET), also known as challenge testing, assesses how well a product's preservative system inhibits microbial growth over time. Vital for products with water content or susceptible to contamination during use. We follow USP <51>, ISO 11930, and industry best practices.

Yeast and Mold Testing

We perform enumeration and speciation testing according to USP and AOAC methods to identify and quantify yeast and mold contamination in supplements, dried foods, and cosmetics.

Raw Material Microbial Testing

We provide tailored microbial analysis to screen for pathogens and total microbial loads in raw botanical powders, extracts, and other ingredients before production, helping ensure supply chain integrity.

Environmental Monitoring

We provide environmental monitoring programs to assess manufacturing facility hygiene and contamination risks, testing surfaces, air, and water to ensure compliance with FDA cGMP and ISO cleanroom standards.

الاختبارات والأساليب المدرجة

  • Total aerobic microbial count (TAMC)
  • Total yeast & mold count (TYMC)
  • Pathogen detection (E. coli, Salmonella, Listeria)
  • Preservative efficacy testing (PET)
  • Yeast & mold enumeration
  • Raw material microbiology

المعايير التنظيمية والامتثال

  • USP <61> Microbial Enumeration
  • USP <62> Specified Microorganisms
  • USP <51> Antimicrobial Effectiveness
  • ISO 11930
  • FDA 21 CFR Part 111
  • AOAC validated methods

القطاعات التي نخدمها

  • Dietary supplements
  • Cosmetics & beauty products
  • Personal care
  • Dry foods & botanicals
  • Amazon FBA sellers
ISO 17025

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📍 إيرفاين · سان دييغو، كاليفورنيا
⏱ 48–72 hours وقت التسليم
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الأسئلة الشائعة

What microbiology tests does Qalitex perform?

Qalitex performs total aerobic microbial count (TAMC), total yeast and mold count (TYMC), pathogen detection for E. coli, Salmonella, Listeria, Staphylococcus aureus, and Pseudomonas, as well as preservative efficacy testing (PET) per USP <51> and ISO 11930.

What is preservative efficacy testing (PET)?

Preservative efficacy testing, also called challenge testing, evaluates whether a product's preservative system can inhibit microbial growth throughout its shelf life. Qalitex performs PET per USP <51> and ISO 11930 standards for cosmetics, supplements, and personal care products.

Which standards does Qalitex follow for microbiology testing?

Qalitex follows USP <61> for microbial enumeration, USP <62> for specified microorganisms, USP <51> for antimicrobial effectiveness, ISO 11930, FDA 21 CFR Part 111, and AOAC validated methods for all microbiology testing.

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إخلاء المسؤولية: نتائج الاختبارات التي تقدمها Qalitex Laboratories هي بيانات تحليلية لأغراض مراقبة الجودة. لا تشكل مشورة قانونية أو تنظيمية أو امتثالية. يتحمل العملاء المسؤولية الكاملة عن ضمان امتثال منتجاتهم لجميع اللوائح الفيدرالية والولائية والمحلية المعمول بها.