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Unit Operations in Tablet Manufacturing Main

Unit Operations in Tablet Manufacturing involves several key stages: 1) Dispensing of raw materials is the first critical step where ingredients are weighed and dispensed according to work orders to avoid cross contamination. 2) Granulation involves processes like wet or dry granulation to form granules which are then dried, dry milled, and blended. 3) Compression uses punches and dies to form tablets of defined size and shape from the granulated material. 4) Coating may optionally be applied to achieve benefits over uncoated tablets. 5) Tablets are finally packed via blister/strip packing or bottle packing before final labeling and packaging.

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Md. Neyamat Ullah
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© © All Rights Reserved
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546 views

Unit Operations in Tablet Manufacturing Main

Unit Operations in Tablet Manufacturing involves several key stages: 1) Dispensing of raw materials is the first critical step where ingredients are weighed and dispensed according to work orders to avoid cross contamination. 2) Granulation involves processes like wet or dry granulation to form granules which are then dried, dry milled, and blended. 3) Compression uses punches and dies to form tablets of defined size and shape from the granulated material. 4) Coating may optionally be applied to achieve benefits over uncoated tablets. 5) Tablets are finally packed via blister/strip packing or bottle packing before final labeling and packaging.

Uploaded by

Md. Neyamat Ullah
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Unit Operations in

Tablet Manufacturing

Prepared by: Md. Neyamat Ullah


M. Pharm
Sr. Officer, Production
Sun Pharmaceutical Bangladesh Ltd.
Tablet:
Tablets may be defined as the solid unit dosage form of medicament or medicaments with or without suitable excipients and
prepared either by molding or by compression.

Stages of Tablet Manufacturing:

Dispensing of Coating (If


Granulation Compression Packing
raw material applicable)
Dispensing of Raw Material:
• Dispensing of Raw material is one of the most critical step in
manufacturing.
• Three basic principles of dispensing activity should drive the
design of any pharmaceutical company.
 Unidirectional flow of materials and personnel
 Segregation between hazardous and non-hazardous materials
 Separation of storage and manufacturing items and spaces.
• All material should be weighed and dispensed according to work
order.
• To avoid chances of cross contamination, dispensing activity
should be carried out in Reverse Laminar Air Flow (RLAF).
• All required utensils like scoop, spatula, etc. should be cleaned after
dispensing of each ingredients.
• All the dispensed material should be stored lot wise on separate
pallet and should be transfer in production accordingly.
Granulation:

Types of Granulation and steps involved in Granulation:

• Sifting • Sifting
• Sifting
• Binder • Premixing

Direct Compression
• Blending
Wet Granulation

Preparation • Compaction /
• Lubrication

Dry Granulation
• Granulation Slugging
• Drying • Dry milling
• Dry milling • Blending
• Blending • Lubrication
• Lubrication
Wet Granulation:

Sifting:
• Process meant for delumping and to remove
foreign particles (if any)
• Material is passed through specified mesh as
mentioned in batch manufacturing record.

Binder Preparation:
• Binder preparation is used in Wet Granulation process.
• Binding agents like Povidone, Starch, HPC, etc.
dissolved in water or solvents like IPA, Methylene
chloride.
• For some product Active Pharmaceutical Ingredient
(API) available in Binder preparation.
Wet Granulation:

Dry Milling:
• Clit mill, Multimill, Comil, etc used for dry milling
operation.
• To get uniform size of granules, dry milling activity
is important.
• Screen size and Mill RPM (Revolution per minute)
is important parameters.

Blending and Lubrication:


• Octagonal or Conta Blenders used for Blending and
Lubrication.
• To increase the flow property Glidants, Disintegrants
agents were added at Blending Stage.
• Lubricating agent like Magnesium stearate were added
in Lubrication stage.
Wet Granulation:

Compaction / Slugging:
• Used in Dry Granulation to form the granules without
addition of binders.
• Mechanical force applied on powdered material to form
the slug.
• Further slugs were milled to form the granules.

Drying:
• Tray dryer is also used for drying of ram material or
granules.
• Inlet temperature and product temperature is
important parameters.
• End point of this process is Loss on drying (LOD).
Compression:

Compression Process :
Compression:

Monolayer Tablets :
• Which is single layer tablets compressed directly.
• Having single or multi dose API.
• Having fixed course of action (Immediate release or
sustain release).

Bilayer Tablets:
• Which is made up of two distinct layers compressed
together with individual layer lying one on top of
another.
• It is combination of two different API or tablet having
two action (Immediate release and sustain release).
Compression:

• Size and shape of Tablets is defined by punches


and dies.
• Punch and dies are used for the product were
according to Batch Manufacturing record.
• Issuance of Punches and dies should be done
from tool room according to SOP.
Coating:

Uncoated Tablets

It is the application of coating material to


the exterior surface of tablet with intention
of achieving benefits and properties to the
dosage form over the uncoated tablets

Coated Tablets
Packing:
Packaging of a pharmaceutical product is aimed at ensuring that medicines arrive safely in the hands of the
patients for whom they are prescribed.

Blister Packing Bottle packing


/ Strip Packing

To Pack Tablet/Capsule in Blister To Pack Tablet/Capsule in Bottle


packing or strip packing. packing.
Tablet/Capsule are packed in After tablets/capsules filling in
Blister/strip by feeding channel and bottle, capping & induction sealing
are done.
detect each tablets. Further labeling & Pack Inset &
Further packing in show box & final packing in shipper.
shipper.
Thank You

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