Microbial Limit Test

These tips shall help the analyst to reduce the analytical errors in Microbial Limit Test and help to get accurate and error free results. The microbial limit test is the quantitative and qualitative assessment of the microbes or microbial contamination test in a sample. This test is performed for:- ...

Introduction to Factory Acceptance Testing (FAT)

I participated in my first Factory Acceptance Testing (FAT) recently, and I wanted to share my experience of what that looked like. FAT is performed during the initial stages of Commissioning, Qualification and Validation (CQV) for new customized equipment purchased for pharmaceutical processes. This ...

Differences between Drug & Dosage Forms

A drug is An active pharmaceutical Ingredient which gives biological or pharmacological effects. Any substance which gives a therapeutic effect can be called as a drug. Example- For the treatment of peptic ulcer disease(PUD) the substance Omeprazole is prescribed, so the substance Omeprazole is a drug ...

Cleanroom Classifications

Cleanroom classifications are established by the measurement of Number of particles 0.5 micron and larger that are contained in 1 m³ of sampled air. Classification is given on two different conditions: 1. At rest: At rest means all the equipment are installed in a clean room and HVAC system is operational ...

Line Clearance Checklist for Compression

– All extraneous materials & equipments/accessories except relevant to this batch are removed – Correct tooling is set in machine – Check and ensure that right IBC has been set up to right compression machine – Waste Bin is cleaned – All the equipment inside the room ...

Line Clearance Checklist for Coating

– All extraneous materials & equipments/accessories except relevant to this batch are removed – Waste Bin is cleaned – All the equipment inside the room including SS table utensils and scoops are cleaned – All materials/ equipments are labeled properly – All protective ...

Line Clearance Checklist for Primary Packing Area

– Quantity of inner carton for over printing to be determined on the basis of actual number of coated tablets received for blistering after coating – All protective clothing of printing personnel i.e. dress, shoes and caps are properly cleaned – All extraneous materials & equipment’s/accessories ...

What is the Autoclave?

Autoclaves are also known as steam sterilizers, and are typically used for healthcare or industrial applications. An autoclave is a machine that uses steam under pressure to kill harmful bacteria, viruses, fungi, and spores on items that are placed inside a pressure chamber. Who invented the autoclave ...

Compress Air Test as per ISO

ISO 8573 was prepared by Technical Committee ISO/TC 118, Compressors, pneumatic tools and pneumatic machines, Subcommittee SC 4, Quality of compressed air. ISO 8573 consists of the following parts, under the general title Compressed air: Part 1: Contaminants and purity classes Part 2: Test methods for ...

Sterile Production

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