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Prepared by :-
Miss. Sanap Deepali S.
M. Pharm 2nd Year
(Sem III).
Roll No.13
Guided By :-
Prof. J. B. Wadekar
M. Pharm
(Pharmacognosy)
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Ahmednagar
(2019-2020) 1
CONTENTS
 Introduction
 Goals
 Veterinary care
 Quarantine
 Surveillance, diagnosis, treatment and control of disease
 Personal hygiene
 Anesthesia and euthanasia
2
 Physical facilities
 Environment
 Animal husbandry
 Record keeping
 Standard operating procedure
 Personnel and training
 Transport of lab animals
3
INTRODUCTION
 It is Committee for the purpose of control and supervision of
experiments on animals.
 Function :
1. Registration of establishments conducting animal
experimentation or breeding of animals for this purpose.
2. Selection and appointment of nominees in the Institutional
Animal Ethics Committees of registered establishments.
3. Approval of Animal House Facilities on the basis of reports of
inspections conducted by CPCSEA.
4. Permission for conducting experiments involving use of
animals.
5. Recommendation for import of animals for use in experiments.
6. Action against establishments in case of violation of any legal
norm/stipulation. 4
GOALS
 The goal of these guidelines is to promote the human care of
animal used in biomedical and behavioral research and
testing.
 To avoid unnecessary pain before, during and after
experiment .
 To provide guideline for -
1. Housing ,care ,breeding and maintenance
2. Source of experimental animals
3. Acceptable experimental procedures for anesthesia and
euthanasia.
5
VETERINARY CARE
 Adequate veterinary care must be provided and is the
responsibility of a veterinarian or a person who has training
or experience in laboratory animal sciences and medicine.
 Observed regularly for sign of illness, injury, or abnormal
behavior.
 Contagious disease – isolated from healthy animal.
6
QUARANTINE
 Separation of newly received animals from those already in
the facility until the health and possibly the microbial status
of newly received animal have been determine.
 A minimum duration of quarantine for small animal-1 week
and for larger animal-6 week.
 An effective quarantine minimizes the chance for
introduction of pathogens into an established colony.
7
SURVEILLANCE, DIAGNOSIS,
TREATMENT AND CONTROL OF
DISEASE
All animal should be observed for signs of illness, injury, or
abnormal behavior by animal house staff (Annexure 1 and 2).
Animals that show signs of a contagious disease should be
isolated from healthy animals in the colony.
8
PERSONAL HYGIENE
 It is essential that the animal care staff maintain a high
standard of personal cleanliness.
 Clothing suitable for use in the animal facility should be
supplied and laundered by the institution.
 It acceptable to use disposable gear such as gloves, masks,
head covers, coats, coveralls and shoe covers.
 Person should change clothing as often as is necessary to
maintain personal hygiene.
 Personnel should not be permitted to eat, drink, smoke or
apply cosmetic in animal rooms.
9
ANESTHESIA
 It must also be ensured that the anesthesia is given for the full
duration of experiment and at no stage the animal is conscious
to perceive pain during the experiment (Annexure – 5).
 Sedatives, analgesics and anesthetics should be used to
control pain or distress under experiment.
10
EUTHANASIA
 It is resorted to events where an animal is required to be
sacrificed on termination of an experiment or otherwise for
ethical reasons.
 Procedure carried out quickly and painlessly in an
atmosphere free from fear or anxiety.
 The choice of a method will depend on the nature of study,
the species of animal to be killed (Annexure – 6).
 Methods:
1. Physical methods- Electrocution, exsanguination,
decapitation, cervical dislocation.
2. Drug administration- Overdose of chloral hydrate,
ketamine, chloroform.
11
 Requirements of method:
I. Death, without causing anxiety, pain or distress with
minimum time lag phase.
II. Minimum physiological and psychological disturbances.
III. Compatibility with the purpose of study and minimum
emotional effect on the operator.
IV. Location should be separate from animal rooms and free
from environmental contaminants.
12
PHYSICAL FACILITIES
 Building materials- Moisture-proof, fire-resistant, seamless
materials are most desirable for interior surfaces including
vermin and pest resistance.
 Corridor- Wide enough to facilitate the movement of
personnel as well as equipment and should be kept clean.
 Utilities- Water lines, drain pipes and electrical connection.
 Animal room doors- Rust, vermin and dust proof. It is
properly within their frames and provided with an
observation window.
 Floors- Smooth, moisture proof, non-absorbent, skid-proof.
13
 Drains- Floor drains are not essential in all rooms used
exclusively for housing rodents.
 Walls & ceilings- Free of cracks, unsealed utility
penetrations, or imperfect junction with doors, ceilings,
floors and corners.
 Storage areas- Separate storage areas should be designed
for feed, bedding, cages and materials not in use.
 Facilities for sanitizing equipment and supplies- An area
for sanitizing cages and ancillary equipment is essential with
adequate water supply.
 Experimental area- Separate area from the place where
animals are housed.
14
ENVIRONMENT
 Temperature and humidity control :-
• Prevents variations due to changing climatic conditions or
differences in the number and kind of room occupants.
• Air conditioning is effective in regulating environmental
parameters.
• Temperature range- 18 to 29°C (64.4 to 84.2oF)
• Relative humidity range- 30% to 70%
 Ventilation :-
• The animal facility and human occupancy areas should be
ventilated separately.
15
 Power and lighting :-
• The electrical system should be safe and provide appropriate
lighting and a sufficient number of power outlets.
• Lighting system must be installed that provides adequate
illumination while people are working in the animal rooms
and a lowered intensity of light for the animals, for e.g.
fluorescent lights.
• A time-controlled lighting system should be used to ensure a
regular diurnal lighting cycle wherever required.
 Noise control :- Noise free environment.
16
ANIMAL HUSBANDRY
 Caging & housing system :-
• Designed carefully to facilitate animal well being, meet
research requirements, and minimize experimental variables.
• Adequate ventilation.
• Meet the biological need of animal.
• Keep the animal dry and clean.
• Cages made of steel or painted steel (Annexure – 3).
• Feeding and watering devices should be easily accessible for
filing, changing, cleaning and servicing.
• Provide space that is adequate, permit freedom of movement
and normal postural adjustments, and have a resting place
appropriate to the species (Annexure – 3).
17
• Provide a comfortable environment.
• Provide an escape proof enclosure that confines animal safety
provide easy access to food and water.
• Keep the animals dry and clean, consistent with species
requirements.
• Facilitate research while maintaining good health of the animals.
• Constructed of sturdy, durable materials and designed to
minimize cross-infection between adjoining units.
• Cages should have smooth, impervious surfaces that neither
attract nor retain dirt and a minimum number of ledges, angles,
and corners.
• Cages, runs and pens must be kept in good condition to prevent
injuries to animals, promote physical comfort, and facilitate
sanitation and servicing.
18
 Sheltered or outdoor housing :-
• Shelter should be accessible to all animals, have sufficient
ventilation, and be designed to prevent build up of waste
materials and excessive moisture.
• Houses, dens, boxes, shelves, perches, and other furnishings
should be constructed in a manner and made of materials that
allow cleaning or replacement.
• Ground-level surfaces of outdoor housing facilities can be
covered with absorbent bedding, sand, gravel, grass, or
similar material that can be removed or replaced when
needed to ensure appropriate sanitation.
• Buildup of animal waste and stagnant water should be
avoided.
19
 Social environment :-
• The effects of social environment on caged animals vary with
the species and experience of the animals.
• Population density can affect reproduction, metabolism,
immune responses, and behavior.
20
RECORD KEEPING
 The Animal House should maintain following records :
1. Animal House plans, which includes typical floor plan, all
fixtures etc.
2. Animal House staff record - both technical and non – technical.
3. Health record of staff animals.
4. All SOPs relevant to the animals.
5. Breeding, stock, purchase and sales records.
6. Minutes of institute Animals Ethics Committee Meetings.
7. Records of experiments conducted with the number of animals
used (copy of Form b).
8. Death Record.
9. Clinical record of sick animals.
10. Training record of staff involved. 21
STANDARD OPERATING PROCEDURE
 Maintain standard operating procedure (SOP) describing
procedures/ methods adapted with regard to animal husbandry,
maintenance, breeding, animal house microbial analysis and
experimentation record.
 SOP should contain following items :-
• Name of author
• Title of SOP
• Date of preparation
• Reference of previous SOP on the same subject and date
• Location and distribution of SOPs with sign of each recipient
• Objectives
• Detailed information of the instruments used in relation with
animals
• Normal value of all parameters. 22
PERSONNEL AND TRAINING
 The selection of animal facility staff, particularly the staff
working in animal rooms or involved in transportation, is a
critical component in the management of an animal facility.
 The staff must be provided with all required protective
clothing (masks, aprons, gloves and gumboots and other
footwear) while working in animal rooms.
 Facilities should be provided for change over with lockers,
wash basin, toilets and bathrooms to maintain personal
hygiene.
 Regular medical check-up is arranged for the workers.
 Persons working in animal house do not eat, drink, smoke in
animal room and have all required vaccination.
 Initial in-house training of staff at all levels is essential.
23
TRANSPORT OF LAB ANIMALS
The main considerations for transport of animals are -
• The mode of transport,
• The containers,
• The animal density in cages,
• Food and water during transit,
• Protection from transit infection, injuries and stress.
24
REFERENCES
 CPCSEA guidelines for laboratory animal facility, Indian
Journal of Pharmacology 2003;35:257-274.
 Kulkarni S K, Common laboratory animals (1999)
Handbook of experimental pharmacology, Vallabh prakashan,
Delhi 3:11-18.
 Subramanian A, Gitanjali B, CPCSEA- A double edged
sword, Indian Journal of Pharmacology, 2003; 35: 7172
25
26

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CPCSEA guidelines for lab animal facility

  • 1. Prepared by :- Miss. Sanap Deepali S. M. Pharm 2nd Year (Sem III). Roll No.13 Guided By :- Prof. J. B. Wadekar M. Pharm (Pharmacognosy) Dr. Vithalrao Vikhe Patil Foundation’s College of Pharmacy Ahmednagar (2019-2020) 1
  • 2. CONTENTS  Introduction  Goals  Veterinary care  Quarantine  Surveillance, diagnosis, treatment and control of disease  Personal hygiene  Anesthesia and euthanasia 2
  • 3.  Physical facilities  Environment  Animal husbandry  Record keeping  Standard operating procedure  Personnel and training  Transport of lab animals 3
  • 4. INTRODUCTION  It is Committee for the purpose of control and supervision of experiments on animals.  Function : 1. Registration of establishments conducting animal experimentation or breeding of animals for this purpose. 2. Selection and appointment of nominees in the Institutional Animal Ethics Committees of registered establishments. 3. Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA. 4. Permission for conducting experiments involving use of animals. 5. Recommendation for import of animals for use in experiments. 6. Action against establishments in case of violation of any legal norm/stipulation. 4
  • 5. GOALS  The goal of these guidelines is to promote the human care of animal used in biomedical and behavioral research and testing.  To avoid unnecessary pain before, during and after experiment .  To provide guideline for - 1. Housing ,care ,breeding and maintenance 2. Source of experimental animals 3. Acceptable experimental procedures for anesthesia and euthanasia. 5
  • 6. VETERINARY CARE  Adequate veterinary care must be provided and is the responsibility of a veterinarian or a person who has training or experience in laboratory animal sciences and medicine.  Observed regularly for sign of illness, injury, or abnormal behavior.  Contagious disease – isolated from healthy animal. 6
  • 7. QUARANTINE  Separation of newly received animals from those already in the facility until the health and possibly the microbial status of newly received animal have been determine.  A minimum duration of quarantine for small animal-1 week and for larger animal-6 week.  An effective quarantine minimizes the chance for introduction of pathogens into an established colony. 7
  • 8. SURVEILLANCE, DIAGNOSIS, TREATMENT AND CONTROL OF DISEASE All animal should be observed for signs of illness, injury, or abnormal behavior by animal house staff (Annexure 1 and 2). Animals that show signs of a contagious disease should be isolated from healthy animals in the colony. 8
  • 9. PERSONAL HYGIENE  It is essential that the animal care staff maintain a high standard of personal cleanliness.  Clothing suitable for use in the animal facility should be supplied and laundered by the institution.  It acceptable to use disposable gear such as gloves, masks, head covers, coats, coveralls and shoe covers.  Person should change clothing as often as is necessary to maintain personal hygiene.  Personnel should not be permitted to eat, drink, smoke or apply cosmetic in animal rooms. 9
  • 10. ANESTHESIA  It must also be ensured that the anesthesia is given for the full duration of experiment and at no stage the animal is conscious to perceive pain during the experiment (Annexure – 5).  Sedatives, analgesics and anesthetics should be used to control pain or distress under experiment. 10
  • 11. EUTHANASIA  It is resorted to events where an animal is required to be sacrificed on termination of an experiment or otherwise for ethical reasons.  Procedure carried out quickly and painlessly in an atmosphere free from fear or anxiety.  The choice of a method will depend on the nature of study, the species of animal to be killed (Annexure – 6).  Methods: 1. Physical methods- Electrocution, exsanguination, decapitation, cervical dislocation. 2. Drug administration- Overdose of chloral hydrate, ketamine, chloroform. 11
  • 12.  Requirements of method: I. Death, without causing anxiety, pain or distress with minimum time lag phase. II. Minimum physiological and psychological disturbances. III. Compatibility with the purpose of study and minimum emotional effect on the operator. IV. Location should be separate from animal rooms and free from environmental contaminants. 12
  • 13. PHYSICAL FACILITIES  Building materials- Moisture-proof, fire-resistant, seamless materials are most desirable for interior surfaces including vermin and pest resistance.  Corridor- Wide enough to facilitate the movement of personnel as well as equipment and should be kept clean.  Utilities- Water lines, drain pipes and electrical connection.  Animal room doors- Rust, vermin and dust proof. It is properly within their frames and provided with an observation window.  Floors- Smooth, moisture proof, non-absorbent, skid-proof. 13
  • 14.  Drains- Floor drains are not essential in all rooms used exclusively for housing rodents.  Walls & ceilings- Free of cracks, unsealed utility penetrations, or imperfect junction with doors, ceilings, floors and corners.  Storage areas- Separate storage areas should be designed for feed, bedding, cages and materials not in use.  Facilities for sanitizing equipment and supplies- An area for sanitizing cages and ancillary equipment is essential with adequate water supply.  Experimental area- Separate area from the place where animals are housed. 14
  • 15. ENVIRONMENT  Temperature and humidity control :- • Prevents variations due to changing climatic conditions or differences in the number and kind of room occupants. • Air conditioning is effective in regulating environmental parameters. • Temperature range- 18 to 29°C (64.4 to 84.2oF) • Relative humidity range- 30% to 70%  Ventilation :- • The animal facility and human occupancy areas should be ventilated separately. 15
  • 16.  Power and lighting :- • The electrical system should be safe and provide appropriate lighting and a sufficient number of power outlets. • Lighting system must be installed that provides adequate illumination while people are working in the animal rooms and a lowered intensity of light for the animals, for e.g. fluorescent lights. • A time-controlled lighting system should be used to ensure a regular diurnal lighting cycle wherever required.  Noise control :- Noise free environment. 16
  • 17. ANIMAL HUSBANDRY  Caging & housing system :- • Designed carefully to facilitate animal well being, meet research requirements, and minimize experimental variables. • Adequate ventilation. • Meet the biological need of animal. • Keep the animal dry and clean. • Cages made of steel or painted steel (Annexure – 3). • Feeding and watering devices should be easily accessible for filing, changing, cleaning and servicing. • Provide space that is adequate, permit freedom of movement and normal postural adjustments, and have a resting place appropriate to the species (Annexure – 3). 17
  • 18. • Provide a comfortable environment. • Provide an escape proof enclosure that confines animal safety provide easy access to food and water. • Keep the animals dry and clean, consistent with species requirements. • Facilitate research while maintaining good health of the animals. • Constructed of sturdy, durable materials and designed to minimize cross-infection between adjoining units. • Cages should have smooth, impervious surfaces that neither attract nor retain dirt and a minimum number of ledges, angles, and corners. • Cages, runs and pens must be kept in good condition to prevent injuries to animals, promote physical comfort, and facilitate sanitation and servicing. 18
  • 19.  Sheltered or outdoor housing :- • Shelter should be accessible to all animals, have sufficient ventilation, and be designed to prevent build up of waste materials and excessive moisture. • Houses, dens, boxes, shelves, perches, and other furnishings should be constructed in a manner and made of materials that allow cleaning or replacement. • Ground-level surfaces of outdoor housing facilities can be covered with absorbent bedding, sand, gravel, grass, or similar material that can be removed or replaced when needed to ensure appropriate sanitation. • Buildup of animal waste and stagnant water should be avoided. 19
  • 20.  Social environment :- • The effects of social environment on caged animals vary with the species and experience of the animals. • Population density can affect reproduction, metabolism, immune responses, and behavior. 20
  • 21. RECORD KEEPING  The Animal House should maintain following records : 1. Animal House plans, which includes typical floor plan, all fixtures etc. 2. Animal House staff record - both technical and non – technical. 3. Health record of staff animals. 4. All SOPs relevant to the animals. 5. Breeding, stock, purchase and sales records. 6. Minutes of institute Animals Ethics Committee Meetings. 7. Records of experiments conducted with the number of animals used (copy of Form b). 8. Death Record. 9. Clinical record of sick animals. 10. Training record of staff involved. 21
  • 22. STANDARD OPERATING PROCEDURE  Maintain standard operating procedure (SOP) describing procedures/ methods adapted with regard to animal husbandry, maintenance, breeding, animal house microbial analysis and experimentation record.  SOP should contain following items :- • Name of author • Title of SOP • Date of preparation • Reference of previous SOP on the same subject and date • Location and distribution of SOPs with sign of each recipient • Objectives • Detailed information of the instruments used in relation with animals • Normal value of all parameters. 22
  • 23. PERSONNEL AND TRAINING  The selection of animal facility staff, particularly the staff working in animal rooms or involved in transportation, is a critical component in the management of an animal facility.  The staff must be provided with all required protective clothing (masks, aprons, gloves and gumboots and other footwear) while working in animal rooms.  Facilities should be provided for change over with lockers, wash basin, toilets and bathrooms to maintain personal hygiene.  Regular medical check-up is arranged for the workers.  Persons working in animal house do not eat, drink, smoke in animal room and have all required vaccination.  Initial in-house training of staff at all levels is essential. 23
  • 24. TRANSPORT OF LAB ANIMALS The main considerations for transport of animals are - • The mode of transport, • The containers, • The animal density in cages, • Food and water during transit, • Protection from transit infection, injuries and stress. 24
  • 25. REFERENCES  CPCSEA guidelines for laboratory animal facility, Indian Journal of Pharmacology 2003;35:257-274.  Kulkarni S K, Common laboratory animals (1999) Handbook of experimental pharmacology, Vallabh prakashan, Delhi 3:11-18.  Subramanian A, Gitanjali B, CPCSEA- A double edged sword, Indian Journal of Pharmacology, 2003; 35: 7172 25
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