Business Plan for Pharmaceutical manufacturing, requirements, machinery and equipment

Starting Pharmaceutical manufacturing company is high investment and time consuming process. It can be successful only when if you have proper business plan. Before starting you need to work out at number of aspects. Premises area and machinery/equipment are one of first priority aspect before going in process of starting manufacturing unit.

Pharma manufacturing plant could have number of sections depend at investment and coverage. You can start with one or more of sections. Common sections that could be a part of manufacturing unit are:

• External Preparation section
• Liquid/Syrup Section
• Tablet Section
• Capsule Section
• Parenteral Section
• Powder Section
• Ophthalmic preparation section
• Inhaler preparation section
• Suppositories section
• Surgical dressing section

In this article, we will know about minimum area required and machinery required to start own manufacturing unit in pharma sector. Few machinery could be used for more than one section i.e. packaging, mixer, driers, weighing machines, granulator, sifters etc. You will need only one equipment in that case for many sections.

Read: Layout and Challenges for pharmaceutical manufacturing plant

REQUIREMENTS OF PLANT AND EQUIPMENT

External Preparations Section:

External preparation i.e. Dusting powders, creams, lotions, ointments, topical solutions etc requires following minimum requirements and equipments to get approval from drug department for manufacturing of these products:

• Mixing and storage tanks (stainless steel),
• Jacketted Kettle (steam, gas or electrically heated),
• Mixer (electrically operated)
• Planetary mixer
• A colloid mill or a suitable emulsifier.
• A triple roller mill or an ointment mill.
• Liquid filling equipment (electrically operated).
• Jar or tube filling equipment (electrically operated)

Area Required:  For ancillary area, minimum of ten square meter area is required.
Note:For formulation area for external and internal use should be separate to avoid mixing.

Liquid Preparations for Oral Use:(Liquid Section)

Most commonly used are Syrups, Elixirs, Emulsions, suspensions etc.

• Mixing and storage tanks (stainless steel),
• Jacketted Kettle / Stainless steel tank (steam, gas or electrically heated).
• Portable stirrer (electrically operated)
• A colloid mill or suitable emulsifier (electrically operated)
• Suitable filtration equipment (electrically operated)
• Semi-automatic/automatic bottle filling machine
• Pilfer proof cap sealing machine.
• Water distillation unit or deioniser
• Clarity testing inspection units.

Minimum Area Required: Thirty sq. meter for basic installation and for ancillary area minimum of 10 sq. meter is recommended.

Solid Dosage Form (Tablet Section)

Partition Required:

• Mixing, Granulation and Drying section.
• Tablet compression section.
• Packaging section (strip/blister machine wherever required).
• Coating section (wherever required).

Equipments Section wise:

Granulation-cum-Drying section

• Disintegrator and sifter
• Powder mixer
• Mass mixer/Planetary mixer/Rapid mixer granulator.
• Granulator
• Thermostatically controlled hot air oven with trays (preferably mounted on a trolley)/Fluid bed dryer.
• Weighing machines.

Compression section.

• Tablet compression machine, single/multi punch/rotatory.
• Punch and dies storage cabinets.
• Tablet de-duster
• Tablet Inspection unit/belt.
• Dissolution test apparatus
• In-process testing equipment like single pan electronic balance, hardness tester, friability and disintegration test apparatus.
• Air-conditioning and dehumidification arrangement (wherever necessary)

Packaging section.

• Strip/blister packaging machine.
• Leak test apparatus (vacuum system)
• Tablet counters (wherever applicable)
• Air-conditioning and dehumidification arrangement (whereever applicable)

Area Required for above mentioned sections is a minimum area of sixty square meters for basic installation and twenty square meters for Ancillary area is recommended for un-coated tablets.

Coating section,

• Jacketted kettle (steam, gas or electrically heated for preparing coating suspension).
• Coating pan (stainless steel)
• Polishing pan (where applicable)
• Exhaust system (including vacuum dust collector)
• Air-conditioning and dehumidification arrangement
• Weighing balance

For coating section, minimum of thirty square meter area is required for equipment installation and ten square meter for ancillary is recommended.
All process is done in separate area with separate equipments and process i.e. mixing, granulation, drying, compression etc.

Powders Section:

Equipments Required:

• Disintegrator
• Mixer (electrically operated)
• Sifter.
• Stainless steel vessels and scoops of suitable sizes.
• Filling equipment (electrically operated).
• Weighing balance

Required Area is minimum of thirty sq. meter for basic installation. For actual blending, an extra room should be available.

Capsules Section:

Capsule section should be suitably air-conditioned and dehumidified with airlock arrangement.  

Equipment:

• Mixing and blending equipment (electrically or power driven)
• Capsules filling units (preferably semi automatic or automatic filling machines)
• Capsules counters (wherever applicable)
• Weighing balance
• Disintegration test apparatus
• Capsule polishing equipment
• Air conditioner and De-moisturizer 

Required area is twenty five sq. meter for basic installation and ten sq. meter for ancillary.

Surgical Dressing Section:

Equipments:

Dressings other than Absorbent Cotton Wool, namely:-

• Rolling machine
• Trimming machine
• Cutting equipment
• Folding and pressing machine for gauze
• Mixing tanks for processing medicated dressing
• Hot air dry oven
• Steam sterilizer or dry heat sterilizer or other suitable equipment
• Work tables/benches for different operations

Minimum Required area is thirty sq. meter for basic installation for medicated and non medicated separately.

Ophthalmic Preparations Section:

Fully air locked, sterile and enclosed area is required for Ophthalmic products.  

Equipment:

• Thermostatically controlled hot air ovens (preferably double ended)
• Jacketted kettle/stainless steel tanks (steam, gas or electrically heated)
• Mixing and storage tanks of stainless steel/Planetary mixer
• Colloid mill or ointment mill
• Tube filling and crimping equipment (semi-automatic or automatic filling machines)
• Tube cleaning equipment (air jet type),
• Tube washing and drying equipment, if required
• Automatic vial washing machine
• Vial drying oven
• Rubber bung washing machine
• Sintered glass funnel, Seitz filter and filter candle (preferably cartridge and membrane filters).
• Liquid filling equipment (semi-automatic or automatic filling machines)
• Autoclave (preferably ventilator autoclave)
• Air conditioning and dehumidification arrangement (preferably centrally air conditioned and dehumidification system)
• Laminar airflow units

Minimum Area required for ophthalmic products is twenty five sq. meter for basic installation and ten sq. meter for ancillary. Area for external and internal preparation should be separate to prevent contamination.

Pessaries and Suppositories Section:

Equipments are:

• Mixing and pouring equipment
• Molding equipment
• Weighing devices

Required area is twenty sq. meters for basic installation

Inhalers and Vitralle Section:

Equipments:

• Mixing equipment
• Graduated delivery equipment for measurement of the medicament during filling
• Sealing equipment.

Required area is twenty sq. meters for basic installation

For Repacking of Drugs and Pharmaceutical Chemicals:

Equipments:

• Powder dis-integrator
• Powder sifter (electrically operated)
• Stainless steel scoops and vessels of suitable sizes
• Weighing and measuring equipment.
• Filling equipment (semi-automatic / automatic machines).
• Electric sealing machine.

Required area is twenty sq. meters for basic installation

Parenteral Section:

Partitions in Parental Section:

Parenteral preparations in glass containers Water management area: this includes water treatment and storage

• De-ionised water treatment unit
• Distillation (multi-column with heat exchangers) unit
• Thermostatically controlled water storage tank
• Transfer pumps
• Stainless steel service lines for carrying water into user areas

Containers and closures preparation area: This includes washing and drying of ampoules, vials, bottles and closures

• Automatic rotary ampoule/vial/bottle washing machine having separate air, water distilled water jets
• Automatic closures washing machine
• Storage equipment for ampoules, vials, bottles and closures
• Dryer/sterilizer (double ended)
• Dust proof storage cabinets
• Stainless steel benches/stools

Solution preparation area: This includes preparation and filtration of solution

• Solution preparation and mixing stainless steel tanks and other containers
• Portable stirrer
• Filtration equipment with cartridge and membrane filters/bacteriological filters
• Transfer pumps
• Stainless steel benches/stools

Filling, capping and sealing area:

• Automatic ampoule/vial/bottle filling, sealing and capping machine under laminar air flow workstation.
• Gas line (Nitrogen, Oxygen, Carbon dioxide) wherever required.
• Stainless steel benches / stools

Sterilization area

• Steam sterilizer preferably with computer control for sterilization cycle along with trolley sets for loading/unloading containers before and after sterilization)
• Hot air sterilizer (preferably double ended)
• Pressure leak test apparatus

Quarantine area

• Storage cabinets
• Raised platforms/steel racks

Visual inspection area

• Visual inspection units (preferably conveyor belt type and composite white and black assembly supported with illumination)
• Stainless steel benches/stools

Packaging area

• Batch coding machine (preferably automatic)
• Labelling unit (preferably conveyor belt type)
• Benches/stools

Minimum area required for parental preparation is one hundred and fifty sq. meter for the basic installation and one hundred sq. meter for ancillary activities.

Read here: Documentations and procedure for applying pharmaceutical manufacturing license

Hope above information was useful to you…

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