**To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference;…
There are three basic classifications of airlocks that are physically the same, but only the pressure cascade regime differs. Cascade Airlock:- These airlock are very…
HVAC DESIGN ASHRAE 62.1 Ventilation for ACC – Acceptable Indoor Air Quality ASHRAE 189 Standard for the Design of High-Performance Green Buildings ASHRAE 90.1…
GMP:- GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced…
Definition of Six Sigma:- Six Sigma is a smarter way to manage business or department. It is a vision of quality that equates with only…
A set of tooling consists of upper punch, lower punch, and die. The upper punch has a shorter stem. The lower punch stem is…
Introduction:- Pharmaceutical equipment and high purity water systems are designed so that product contact surfaces are not reactive, additive, or absorptive so the drug product…
Pharmaceutical steam is classified into two types based on their respective sources. These are: 1) Utility-Boiler produced steam, hereafter called Utility Steam. 2) Non-Utility Boiler…
UNIDIRECTIONAL AIRFLOW:- In a unidirectional airflow system, air is uniformly introduced through HEPA filters from one entire surface of the room, such as the ceiling…
SANITIZATION:- Microbial control in water systems is achieved primarily through sanitization practices. Systems can be sanitized using either thermal or (photo-) chemical means. THERMAL SANITIZATION:-…
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