4. .
Equipment and types of equipment.
WHO guidelines for Equipment's .
Equipment selection.
Design, size, location and construction of equipment.
Equipment construction.
Equipment identification.
Cleaning and maintenance of Equipment.
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5. .
What is an Equipment ????
Equipment may be defined as a physical entity which is used to carry
out a general or specific activity in the plant.
Types of Equipment
Single piece:
E.g. Tablet compression machine, a mixer, HPLC, Weighing balance
etc.
Integrated system:
E.g. Water demineralizing plants, an air handling system etc.
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6. .
WHO Guidelines for a equipment's.
Equipment must be located, designed, adapted and maintained to suit the
operation to be carried out.
Equipment should be installed in such a way as to minimize any risk of error
or of contamination.
Production equipment should be designed, located, and maintained to serve
its indented purpose.
Production equipment should be designed, so that it can be easily and
thoroughly cleaned on schedule basis.
Production equipment should not present any hazard to the products.
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7. .
Equipment selection:
Selection of equipment has both strategic and financial impact on the
companies.
It is an essential for any company because it has direct influence on the
success of the product facilities by optimum cost, improving quality, safety
and reducing environmental hazards.
Factors that affects selection of equipment's are:
a) Operating criteria
b) Availability of spares and servicing
c) Maintenance
d) Environmental issues
e) Availability of design and maintenance manuals.
f) Cost.
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8. .
Design, size, location and construction of Equipment :
Design:
Equipment is made on requirement of user based on URS [user
requirement specification].
Capacity: In put [holding]and output capacity
What material [API etc.]will be processed
Which cleaning method will be used
How to validate
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9. .
Size: batch size/vol. of material decides the size of equipment.
1. Physical dimension: L × W× H of equipment, size of room, avoid difficulties in
taking in to room ,new wall construction etc.
2. Holding and output capacity ,minimum or maximum volume of material
decides size.
Autoclave for small scale Autoclave for large scale
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10. .
Location:
Equipment should be located to avoid congestion and should be
properly identified to assure that products do not become admixed
or confused with one another.
Water ,steam and pressure or vacuumed lines, where applicable,
should be installed so as to be easily accessible during all phases of
operation. Hey should be clearly identified.
Support system such as heating, ventilation, air conditioning,
water[such as potable, purified, distilled,] steam, compressed air and
gases[example nitrogen]should function as designed and
identifiable.
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11. .
Equipment construction
Equipment shall be constructed so that surfaces that contact
components and drug products shall not be reactive or absorptive
as it alter the safety, identity, strength, quality or purity of the drug
product.
The construction material used for parts which are direct contact
with product and manufacturing vessels may be stainless steel
316 or borosilicate glass and tubing should be capable of being
washed and autoclaved.
Any substance required for operation such as lubricants or coolant
shall not come into contact with components, drug product
container closures or drug products.
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12. .
Equipment identification:
WHO Guideline
All compounding and storage container, processing lines and major
equipment used during production of a batch of drug products shall be
properly identified at all times to indicate their content.
Major equipment shall be identified by a distinctive identification no. or code
that shall be recorded in the batch production record to show the
specification equipment used in the manufacture of each batch of drug
product.
Fixed pipe work should be clearly labelled to indicate the contents and ,where
acceptable, the direction of flow.
All service piping and device should be adequately marked and special
attention paid to the provision of non-interchangeable connection or
adaptors for dangerous gases and liquids.
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13. PRODUCTION MANAGEMENT:
Introduction:
Production
Definition: production is the method of turning Raw materials or inputs into
finished goods or products in a manufacturing process. In other word, it mean
the creation of something from basic inputs.
Production management:
Production management deals with converting raw materials into finished
goods or products. It brings together the 6M i.e. men, money, machines,
materials, method and markets to satisfy the wants of the people.
It coordinates use of personal ,land ,budling and equipment, including
management of inventory assets.
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14. .
Objective of production management
1. Right Quality.
2. Right quantity.
3. Predetermined time.
4. Pre- established cost.
Other objective are:
1. Machinery and equipment.
2. Materials
3. Manpower.
4. Supporting service.
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15. .
The objective of the production management is ‘to produce good service of
right quality and quantity at the right time and right manufacturing cost’.
1. Right quality
The quality of product is established based upon the customers needs.
The right quality is not necessarily best quality.it is determined by the cost of
the product and the technical characteristics as suited to be the specific
requirements.
2. Right quantity
The manufacturing organization should produce the products in right number.
If they are produces in excess of demands the capital will block up in the form
of inventory and the quantity is produced in short of demand, leads to
shortage of products.
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16. .
3.Right time
TimeLine of delivery is one of the important parameter to judge the
effectiveness of production department.
So, the production department has to make the optimal utilization of input
resources to achieve its objective.
4.Right manufacturing cost
Manufacturing cost are established before the production is actually
manufactured.
Hence, all attempts should be made to produced the product at pre-
established cost, so as to reduced the variation between actual and the
standard [pre-established]cost.
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17. .
5 P’s of production management:
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