sterile manufacturing.pptx

MANUFACTURING:
ECONOMICS AND DEMAND
CONSIDERATION
Presented By : Prof Jyotsna P. Khedkar
M. Pharm (Pharmacology)
Prof. Jyotsna Khedkar PSGVPM's IOP Shahada

LEARNING OUTCOMES
After reading this topic student may be able to :
1. Enlist factors determine economic condition of
hospital.
2. Enlist factors affecting make or buy decision.
3. Explain Various demand estimation methods

For starting manufacturing in hospital “Hathi committee” gives
various recommendations for IV fluids.
There are some reasons behind starting a manufacturing unit in
the hospital. These are as follows:
1. Substandard drugs are provided by suppliers.
2. Several drugs are unavailable in a hospital
because of less profit.
3. Most of the drugs are not supplied on time,
because of the delay patient face inconvenience.
4. Cost of drugs is also one of the reasons for
manufacturing
INTRODUCION

Factors which determine the Economy of a hospital:
There are some factors which determine the economy of the hospital
are as follows:
1) Material Requirement:
The raw material and packaging material and other material
requirements for manufactured can be determined by various
formula. If a particular raw material or packaging material is
calculated by many different formulae enter the quantity of such
material on a spreadsheet and total of all the quantities of each item
is done. Prof. Jyotsna Khedkar PSGVPM's IOP Shahada

2) Manufacturing requirements:
For manufacturing requirement, the consumption rate for each item is
calculated by reviewing the previous record and comparing these
figures with the present requirement.
3) Manufacturing staff: Too many or too fewer personnel disturb the
manufacturing programme. The manufacturing section must always
be supervised by a technically competent and legally qualified
pharmacist who will support technical and non-technical persons

4) Manufacturing capacity:
manufacturing capacity depends on the availabilities of
equipment and economy of a hospital to full fill the
requirement. The selection of equipment is made only the
basis of a multiple user system. These prevent accumulating
of costly equipment unless otherwise required

5) Manufacturing Equipment:
The type and size of manufacturing equipment required in a
hospital depend upon manufacturing program like the
quantities to be produced, duration of production time,
availability of physical facilities and availability of persons.
6) Operating cost:
operating cost include both direct that is the labour cost of
material etc and indirect cost like maintenance of a building.

Factors affecting Make or Buy decision:
1) Quality: Quality of purchased from outside drugs and
manufactured in the hospital are compared. If the quality of
manufacturing drug is better than the manufactured in-
hospital drugs then the decision of manufacturing in
hospital is taken. In case of large volume parenteral, the
hospital manufactured itself because outside purchasing
may compromise the quality of large volume parenteral.

2) Quantity:
When the drugs required in less quantity the
manufacturing in hospital affect the economy of the
hospital due to raw material requirement,
procurement problem etc. drugs which are used in
very small quantities as outside supplies may not have an
interest and may not have supplied. Similarly, drugs which
are used in large quantities are manufactured in
hospital after deciding break-even quantity of production.

3) Cost:
Cost of buying from outside is compared with the cost
of manufacturing in hospitals. If the cost of a
manufactured drug is low then the decision is to make.
If the cost of the purchased drug is less then the
decision is to buy has been taken.

4) Services:
Manufacturing in hospital assures the regular supply of
drugs and provide good services while purchased from
outside drug supply may not assure the regular supply of
drugs. Assured supply is also a valid reason for
manufacture it. Interruption in supplies may affect
hospital activities.

ESTIMATION OF DEMAND
There are three methods of demand estimation:
1. Judgmental:
This methods of estimation refer to the judgment
of clinical and pharmacy staff of a hospital is taken
on their own experience about the quantity that
will be required for particular drugs.

2. Past History:
In this method with the help of records the requirements
of the drug for future is determined.

3. Casual method:
In this methods estimation of demand is carried
using some casual factors. Examples-i) Demand of
whole blood is related to admission in the casualty
or emergency ward.
ii) Demand for antibiotics is related to many
patient’s infections every month.

STERILE MANUFACTURE
Presented By : Prof Jyotsna P. Khedkar
M. Pharm (Pharmacology)
P.S.G.V.P.M’s IOP Shahada

LEARNING OUTCOMES
• After reading this topic student will able to :
1. Understand large and small volume parenteral.
2. List out and explain facilities, requirements, layout,
production, planning, man-power.

Definition:
• Sterile manufacturing: involves creating a medication in an
environment free from viruses, bacteria or any other
potentially infectious microorganisms. This type of
compounding is used for medications that will be
administered either through an IV injection or directly into
the eyes.

Large volume parenteral (LVPs)
• include intravenous solutions sold in bags or bottles
containing 100 ml or greater (250 ml, 500 ml, 1 L). They are
packed in these large volumes because larger quantities
are typically required.

Small volume parenteral (SVPs)
• solution are usually 100 ml or less and are packaged in
different ways depending on the intended use. If the SVP is
a liquid that is used primarily to deliver medications, it is
packaged in a small plastic bag called a minibag of 50-100
ml (minibags look like small plastic LVP bags).

Difference Between SVP and LVP
Sr. No. PARAMETERS SVP LVP
1 Volume 100ml or less 101-1000ml
2 Route IV, IM, SC IV-LVP & non-IV-LVP
3 Dosage unit Single or Multiple Single
4 Preservative Used Not Used
5 Buffers Used Not used
6 Formulation Solution, Emulsion, Suspension Solution & o/w nutrient
emulsion
7 Isotonicity Not essential Must
8 Pyrogenicity Not essential Must
9 Use Therapeutic &diagnostic Nutrition, detoxification &
during surgery

Requirements for sterile manufacturing:
• For sterile manufacturing following types of equipment are
necessary to meet the requirement of D & C (drug and cosmetic act).
1. Storage equipment for ampoules and vials.
2. Storage cabinet.
3. Water steel ( Distillating steel )
4. Ampoule washing machine.

5. Ampoule drying machine.
6. Filling and sealing machine.
7. Signature glass funnel.
8. Filter press.

9. Hot air oven.
10. Autoclave.
11. Equipment of evaluation and quality control.
12. Labelling and packing unit.

Facilities:
• Manufacturing facilities include the maximum degree of cleanliness
in an aseptic filling room while as surrounding area provide standard
cleanliness which is slightly lower than dose maintains in aseptic
rooms. For construction, it requires the best material and design.
• The sealing and floors should be constructed of material which is
easy to clean and non-porous to prevent the accumulation of dust
and moisture.

1. Environmental control:
Standard of environmental control make very depending
upon the area involved, the processing etc. it requires
good environmental control before and during processing.

2. Traffic control:
Environmental control can be maintained easily if there is known
in and out the traffic of supplies and person. They should be
permitted to enter aseptic areas after a prescribed procedure like
changing clothes, washing their hands, putting on gloves, shoes,
hats and face mask.
• Once they enter the aseptic area they are not permitted to
move out of the area till the manufacturing cycle is completed
unauthorized person should not be permitted into aseptic area.

3. Maintenance:
Generally cleaning is done at the end of the working day or
during the night it includes all the surface like ceiling wall,
floors, counter etc. cleaning should never be done just before
the beginning of production of doses. To permit the setting
from the air and allow for the completion of the action of
disinfectant and UV radiation

4. Disinfection:
All the surfaces should be disinfected in the aseptic area and
effective liquid disinfectant should be spray or wipes on all
surfaces.

5. Irradiation:
Ultraviolet rays are antibacterial in action, hence they
produce a disinfectant action on directly irradiative surfaces.
Direct irradiation of room is done when personnel are not
present. It acts as a good source of reducing the bacterial
count on the working benches, floor. The best practice is to
use U.V. light rays in the cold cathode mercury vapor lamp
which provides a high proportion of radiations.

6. Air control:
The air in the sterile areas can be one of the greatest sources
of contamination. Air cleaning is done by various treatments.

Personnel (Man Power Requirement)
• Following are some requirement of personnel in the
aseptic area.
1. They should be of good health and free from any
dermatological conditions.
2. They must have some knowledge about the basic principle
of the aseptic process.

3. Movement within the room should be minimum and in
and out movement are restricted during filling operation.
4. Every individual shall use fresh sterile uniform after every
break period.
5. Uniform consist of overall for man and women which
completely cover the hair, face mask, plastic shoes, sterile
rubber gloves, goggle.

Aseptic Area/Clean area
Aseptic area can be classified on the basis of nature of
environment
• Class 100 : Area where number of particles of size > 0.5
micron per cubic feet of air should not be more than 100.

• Class 10,000 : Number of particles per cubic feet of air of a
size > 0.5 micron and > 5.0 micron should not be more
than 10,000 and 70 respectively

• Class 100,000 : Number of particles per cubic feet of air of
air of a size> 0.5 micron and 5.0 micron should not be
greater than 100,000 and 700 respectively.

Laminar airflow
• HEPA means HIGH Efficient Particulate Air filter.
• HEPA filters are of different sizes fitted into th ceiling of
aseptic area and Laminar air flow bench.
• Laminar air flow bench is used to perform sterility and
other micro-biological testing like bio-assay
• There are two types:
• Vertical
• Horizontal

• A relatively new air control system based on laminar
airflow principle has greatly improved the environmental
control of the aseptic area for this purpose clean filtered
aseptic air is blown evenly through hooded areas or side of
an entire room.

• The airflow must be uniform in velocity and direction
throughout any given cross-section of the area being
exhausted from the opposite side. The air velocity
employed should be about 100ft/ml. contamination is
prevented because it is swept away with the airflow.

The layout of the sterile product area:
Stock
Room
Compounding
Area
Aseptic
Area
Quarantine
Area
Storage
&
Transport
Cleanup
area Sterilization
Packing
and labelling

1. Cleanup area.
2. Preparation or compounding area.
3. Aseptic area.
4. Quarantine area.
5. Labelling and packing.

1. Clean up area:
This area has walls and sealing with a film coating material.
e.g. Vinyl, Epoxy. There should be no holes, corners on
projection. There should be free from dirt and microbes. The
room should undergo a minimum of 10 – 15 air changes/hrs.
All incoming air should be passed through a filter with an
efficiency of 95%.

2. Preparation and compounding area:
• In this area formula is compounded and for these, the area
doesn't have to be aseptic but controlling majors are
provided to control the dust. Generated from weighing and
compounding procedure. Cabinet and counter are
generally made up of stainless steel.

3. Aseptic area:
• The sealing walls and floor must be sealed properly so that
they can be wash and disinfected when required. All the
counter are made up of stainless steel and they are
constructed in such a way that there is no dirt particle are
accumulated.
• Storage tank, mixing tank containing compounded
products should remain outside the aseptic area and then
the product is filled into the aseptic area.

4. Quarantine area:
• The purpose of the quarantine area is that batches can be
stored physically segregated from either in-process batches
or approved batches in a lock store which excess it's
restricted to a responsible person.

5. Labelling and packing area:
• In these batch and numbering and the overprinting label
should take place. Adequate space is required for
installation of overprinting devices.

sterile manufacturing.pptx

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