Download Gowning and Cleaning

Gowning and Cleaning
Gowning:
•To protect product:
•Protective apparel, such as
head, face, hand and arm
coverings shall be worn to
protect drug products from
contamination
•To protect personnel:
•From potentially hazardous
effects of various materials
•Personal Protective Equipment:
•Various types
exist based on
the nature of
the product
being
manufactured
Cleaning:
•To protect product:
•To prevent contamination that
could alter the safety, identity,
strength, quality or purity
•Materials used in one product
may not be acceptable in the
next product
•For proper equipment function:
•Build-up of residues may
interfere with production
•Dedicated vs. Non-dedicated:
•Requirements are more
stringent for equipment shared
between multiple products
Blending
Objective:
•To promote uniformity:
•Ensures random mixtures of
various particle size fractions:
•Uniformly incorporates the
API and processing aids, such
as colors, lubricants, glidants
and disintegrants
Types of Blenders:
•Diffusion:
•V-Blender
•Tumble Bin
•Convection:
•Ribbon Mixer
•Planetary Blender
•Pneumatic:
•Fluid Bed
Fluid Bed (Pellet) Processing
Objective:
•To apply a layer of material on or
around a solid core:
•For delayed release:
•Release in intestinal tract
instead of stomach
•For sustained release:
•Release of drug over an
extended period of time
Methodology:
•Particles are fluidized in an air
stream
•A coating formulation is sprayed
onto the particles
•Coated particles flow up with the
air, slow and fall back down
•The coating dries on the particles
Compression
Objective:
•To subdivide the bulk blend into
the desired dose
•Formation of a tablet
•Material size and volume are
reduced in response to
external force
•Particle rearrangement
(removal of void volume)
followed by consolidation
Upper
Punch
DIE
DIE
Lower
Punch
Scrapeoff
blade
DIE
Weight
Control
DIE
Lower
Punch
DIE
Lower
Punch
DIE
DIE
DIE
Lower
Punch
Weight
Control
Lower
Punch
DIE
Upper
Punch
DIE
Lower
Punch
Powder Encapsulation
Objective:
•To subdivide the bulk blend into
the desired dose
•Introduction of a precise
amount of a uniform
formulation into a
capsule shell
•Facilitates two-tone
color schemes
(product branding)
•A good option for
poorly compressible
materials and poorly
soluble compounds
Pellet Encapsulation
Objective:
•To subdivide the bulk pellets into
the desired dose
•Introduction of a precise
amount of a uniform
formulation into a
capsule shell
•Facilitates two-tone
color schemes
(product branding)
•Generally utilized
when specially
formulated release
profiles are desired,
i.e. delayed release
or sustained release
A. Feeding &
Orientation
Pellets
Tablet Dosing
(optional)
C. Opening &
Separation
D. Dosing
Closing
B. Transfer
E. Exit wheel
Tablet/Capsule Testing
Objective:
•To ensure finished dosage units
contain the correct quantity of
material and are sufficiently robust
to withstand packaging and
distribution:
•Tablets:
•Weight
•Breaking Strength
(Hardness)
•Thickness
•Friability
•Disintegration
•Capsules
•Weight
•Joined Length
drop
Tablet Coating
Objective:
•To create a continuous film
covering the surface of a tablet for
the following reasons:
•Product identity/
aesthetics/branding
•Taste masking
•Control dusting and exposure
in packaging and distribution
•Chemical stability – light
protection
•Sustained or delayed release
Pharmaceutical Manufacturing
Types of Pharmaceuticals:
•Parenteral Products (injected):
•Solutions, suspensions, emulsions
•Liquid Products (orally ingested):
•Oral solutions, suspensions
•Dry Products:
•Tablets, capsules
Pharmaceutical Formulation =
Henderson – Hasselbalch Equation:
•Active Pharmaceutical Ingredient (API):
•Produces desired therapeutic effect
•The chemical that treats the disease
•Plus Excipients:
•Makes the manufacturing and administration
of a drug practical, feasible and reasonable
•Allows for a convenient dosage for the consumer
•Examples: helps the drug become stable, flow
through equipment, controls the structure of the
drug, dilutes quantity.
pH = pKa + log [ionized]
[unionized]
Dry Products Manufacturing
Stages of Dry Product Manufacturing:
•Combine API and Excipients:
•Dry Blending
•Dry Granulation
•Wet Granulation
•Spray Granulation
•Pellet Processing
•Create Dosage Form:
•Compression
•Encapsulation
•Additional Tablet Unit Operations:
•Film Coating
•Tablet Imprinting
•Packaging
•Bottle Filling
•Blister Filling
•Labeling and Literature
•Secondary Packaging
Dry Products Packaging
• Packaging of drug products
accomplishes the following tasks:
+ Physical and Barrier Protection
+ Containment (grouping of individual
units)
+ Information transmission
+ Marketing
+ Security (tamper-proofing/ childproofing)
+ Convenience
Packaging Types
• Bottles
+ Count in bottle depends on end customer
(hospital to doctor samples)
+ Most popular in the US markets
•Blister packs
+Count dependent on end customer
+Preferred in many other countries
+Provides individual seal of drug product
+Used in “calendar” type of applications