Pharmaceutical automation involves the mechanical processes of handling materials, distributing medcations and manufacturing and packaging formulation in industries.
The pharmaceutical industry recognizes the value of automation.
Automation improves compliance and minimizes deviation by connecting, insturments to electronic systems, so users dont have to manually enter data.
Stability Chambers and Incubators, Dehumidifiers, Grinding, Blending & Batch Mixing, RMG, Capsule Filling, Formulation and Batch Mixing, 21 CFR PART 11.
A stability chamber is a device used to artificially replicate various environmental conditions by procedurally altering just two specific factors. Temperature and relative humidity. A stability chamber is thus used comprehensively in the testing of drugs & medicines in the pharmaceutical industry, to determine the basic shelf-life of the said drugs along with their resistance to environmental changes.
Dehumidifiers are electrical appliances used for reducing the level of humidity in the
air to maintain a balance in the atmosphere.
They are designed for ensuring the best health or comfort in the ambiance. They remove
musty odor and prevent the growth of yeast by extracting water from the air.
They are widely used in residential, commercial, or industrial applications for keeping
the air clean and clear.
In addition to this, they are also used in indoor ice rinks, swimming pools, storage
warehouses, etc.
In Batch Mixing, all ingredients are loaded into the mixer together or in a pre-defined
sequence,
mixed until a homogenous material is produced and discharge from the mixer in a single
lot.
Grinder Machine uses compressed air to be cooled, filtered, and dried. The nozzle forms a
supersonic airflow and is injected into the crushing cavity.
The material is
fluidized under the action of pressure difference. The accelerated material is at the
intersection of multiple nozzles.
In pharmaceutical industry rapid mixer granulator plays vital role to mix the ingredients
and make granules before compression.
For wet granulation, choppers and impellers are mainly responsible in rapid granulator.
This RMG machine is also known in Industries with various key terms as High shear
granulation machine.
Dry Powder granulator, Wet Granulator, Pharma Saizoner, High shear mixer granulator,
high-shear granulator, High Shear Mixer Granulators, Granulator,
Wet Mixing, Rapid Mixer Granulator Machine, Granulation Machine, Rapid Mixer Granulator.
21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the
United States Food and Drug Administration’s (FDA) guidelines on using electronic
records and electronic signatures. Each title of the CFR addresses a different regulated
area, 21 CFR relates to Pharmaceuticals and Medical Devices and Part 11 being applicable
to electronic records and electronic signatures.
At a high level, Part 11 is a law that ensures that companies and organizations
implement good business practices by defining the criteria under which electronic
records and signatures are considered to be accurate, authentic, trustworthy, reliable,
confidential, and equivalent to paper records and handwritten signatures on paper. Part
11 essentially allows any paper records to be replaced by an electronic record, and
allows any handwritten signature to be replaced by an electronic one.