The basic subdivisions are :

Animal Breeding Area - (one species per room). Animal Stock Area - (one species per room). Study/ Experimental Animal Area - (one species, one study per room) Quarantine Area - (one room per species) Staff areas - Office Common Room Changing / Shower / Toilet Facilities. Storage - Food Bedding Equipment long, medium and short term. Service Areas – Sterilizing Services Food Preparation Packing and Dispatch Cage Cleaning and Waste Disposal Systems etc. Laboratory area including special facilities such as: Pathology laboratory: Clinical Chemistry Haematology Analysis Tissue Processing for Histopathology Post Mortem Room. Corridors – Service and Clean Corridors Technical Installations

  Barriers in Use in - Animal and Toxicological Facilities

• The building is situated away from potential hazards (wild or other infected animal populations)

• The building is physically separate from other buildings on same site.

• The building is designed to encourage a one way flow system to increase, isolation between 'clean' and 'dirty' operation.
• Organization of flow of work in and out of the building, carried out in such a way as to minimize the introduction of disease into, or cross contamination within the facility.
• Provision of 'extra' room to allow a routine cycle of room sterilization at periodic intervals ideally at the end of each procedure or study.
• Provision of rodent barriers at the entry to the building and rodent proofing the whole building.
• Provision for insect barriers at all entrances/exits to/from the building.
• Restricted entry of personnel (number of people allowed to enter animal facilities are kept to absolute minimum).
• Enforcement of staff routines,e.g:

• change of footwear
• change of other clothing, including head cover.
• showering plus complete change of clothing

• wearing of face-mask and gloves when handling the animal

• Routine screening of staff to identify those harbouring undesirable organisms.
• Provision and use of sterilizing equipment(eg:autoclave,ultraviolet lock for exit of items only),for sterilization of bedding, cages, bottles and tubes, equipment, water,etc.
• Use of disinfectants for surface cleaning.
• Use of adequate amount of ventilating air, filtered to the appropriate level at supply and/or exhaust points as necessary.
• Use of air pressure differentials to discourage the ingress/egress of air into/from disease-free/infected animal areas.
• Routine and effective quarantining of all incoming animals.

FACILITIES

Facilities are divided into three categories :

• Animal rooms
• Laboratories
• Other facilities

Each category is further subdivided as follows :

  Animal Rooms:

Species: Rodents, Rabbits, Guinea pigs and Hamsters.

Rodent rooms (13 rooms) - Maximum capacity - 5000 animals.
Quarantine (2 rooms);
Breeding (stock) (2 rooms);
Study experimentation (9 rooms);
Acute (2 rooms);
Subacute (2 rooms);
Chronic (2 rooms);
Carcinogenicity (2 rooms);
Spare ( 1 room);
Rabbits/Guinea pigs/Hamsters - Maximum capacity - 500 to 1000 animals
Rooms ( 3 rooms);
Quarantine (1 room);
Breeding / stock ( 1room);
Study/Experimentation ( 1 room);

Ventilation system - animal rooms
Air condition - Ventilation
Room Temperature - 20±2^oC
Relative Humidity - 30-70%
HEPA filter - 0.2 micron (99.9% efficiency)
20-24 (100% fresh) air changes per hour
Clean corridor positive pressure
Animal room, dirty/service corridor negative pressure

Laboratories

Necropsy room

Pathology - Histopathology

Haematology

Clinical chemistry

Other facilities

Conference room

Documentation

Archive

Cleaning and sterilisation

Animal feed , bedding stores

Shower /changing/rest rooms

Incinerator room

  Lighting

12 hour light
12 hour dark cycle
Light intencity 50 - 100 foot candle at cage level
Stand by Generators

  Control

By Building Management System
(Computerised recording of environmental conditions)

  EQUIPMENTS

Laboratory equipments
Some of the important instruments are:

Computerised blood chemistry analyzer Technicon RA 1000 Biochemistry Autoanalyser Computerised hematology analyzer (multi-species capability) Technicon H1*E Hematology Autoanalyser. Leica Automatic tissue processor Leica Automatic paraffin embedder Leica Automatic Motorised microtome Leica Automatic staining machine Zeiss Trinocular microscope Lab India Histoplate Histobath Heating Block Remi Centrifuge Vortex Mixer Tomy Microcentrifuge Double Doored Autoclaves (x2) Hot Air Oven (x2) Computers--/Centralised computer system.

  Animal Room equipments:

-Cages & -Racks
As per space recommendations for Laboratory animals(as per EEC & USA)

Space Allotted For Laboratory Animals

  Other Equipments

1. Autoclave (L) 6ft.X(M)4ft.X(H)6ft. For cages (and racks) sterilisation - double doored autoclave opening into service area and opening out at clean area.
2. Steam jet cleaner
3. Oil fired incinerator

Animal Feed and Water
Animals
Rodents in-house bred
Proposed to import - breeding stock

Health
All lab animals periodically examined / tested for various diseases
(Microbiological, pathological tests)

Feed
Feed given to lab animals are periodically tested for : Chemical and Biological contaminants & Nutritional values

Water
Water used for lab animals is periodically tested for :
Chemical and biological contaminants 
Water filtered - Aquaguard processed

  Quality Assurance Unit(QAU)

As per the GLP, all the activities of OneMonkey are monitored by Staff of Quality Assurance Unit, an Independent Unit of Centre reporting directly to the Director, TRC.

  Responsibilities and Functions of QAU

1. Monitoring study
2. To assure the management that the study is carried out in confirmation with GLP regulations.
3. Maintain - Master Schedule Sheet for all the studies
4. Periodical inspection
5. Periodically send written report to Study Director and Director, R&D
6. Determine no deviation from protocols or SOPs are made without proper authorisation and documentation.
7. Review the study final report.
8. Prepare and sign final statement.

STRENGTHS

Some of the preclinical safety evaluation studies carried-out at the Centre are follows :

  Toxicological Studies

OneMonkey uses rapid and cost effective screening tests based on animal models, micro organisms and to evaluate toxicity, mutagenicity and carcinogenicity of a given compound. Although design is flexible, studies involve exposures of rodents (rats and mice) of both sexes for different periods of time. More detailed or focused studies can be included in study protocols when the existing literature finding of final studies suggest a target organ or system. Clients can choose from a wide spectrum of administration routes. The scope and types of screening studies performed are dictated to a large degree by the data needs for the specific chemical nominated for study.

Acute toxicity studies
Acute limit test (gavage, IP, dermal)
LD50 determinations (all routes)
Skin and eye irritation
Pyrogenicity in rabbits
Subacute/Subchronic Toxicity in rodents and non rodents
Dose range finding studies
14-28 and 90 day oral toxicity studies
Chronic toxicity in rodents and non rodents
18 and 24 month carcinogenicity studies in rodents
24 month toxicity studies in rodents
Customized studies

Special studies
Neurotixicity
Immunotoxicity

  Necropsy And Histopathology Services

Necropsy

Full necropsy including body weight and major organ weight, blood collection (retro-orbital plexus, tail vein or cardiac puncture) appropriate organs/tissues collection, Pathology and Histology including H&E and a variety of special stains comprehensive reports tailored to client needs Photomicrography services.

  Clinical Pathology Services

High quality Clinical Chemistry and Haematology
Data collection and interpretation
Comprehensive testing procedures adaptable to the investigative needs.

  Genetic Toxicity And Cytotoxicity

Mutagenisis Assays
Salmonella thyphimurium (4 strains), E.coli, Sacchromyces cerevisiae/ microsome plate assay.
Micronucleus(MN) Assay
Various animal and human cells (PBL, bone marrow)

  Immuno Toxicology

In Vivo / ex Vivo Evaluation of Immune response
Immune status assessment (total and differential blood all counts)
Histology of the lymphoid organs
Cell counts in biological fluids
Bone marrow counts
General immune status
Total serum protein and immunoglobulin levels
Albumin/globulin ratio
Mixed Lymphocyte Reaction (MLR)
Bone Marrow proliferative activity

  Neurotoxicity Screening

Neurotoxicity is any adverse effect on the structure of function of the central nervous system (CNS) and/or the peripheral nervous system (PNS), related to exposure to a chemical substance.

Functional Observation battery  Unusual responses: Body position and gait, activity level and coordination of movement Bizarre behavior: Head flicking, or head searching Compulsive biting or licking, self-mutilation, circling, walking backwards Presence of :Convulsions or tremors, Increased levels of lacrimation and/or red coloured tears, Increased levels of salivation, Piloerection, Pupillary dilatation or constriction, Unusual respiration (hollow, laboured, dyspnea, gasping, etc.), Forelimb / hindlimb: Grip strength Sensory function: Vision, audition and pain perception Neuropathologyin situ perfusion and fixation suitable for light microscopy, Cross sections of the following areas: Forebrain, center of the cerebrum, midbrain Cerebrum, pons and the medulla oblontata, Spinal cord at the cervical and lumbar swelling, Gasserian ganglia, dorsal root ganglia, Dorsal and ventral root fibers Proximal sciatic nerve (mid thigh and sciatic notch) Sural nerve (at knee) and tibial nerve (at knee), H&E staining and a battery of stains are used to assess components in all appropriate required samples. Three main categories of structural changes are considered : Neuronal body, Neuronal processess (dendrites, axons, myelin sheaths and synapses), Supporting cells (oligodendrocytes, strocytes and microglia in the CNS and Schwan cells, satellite cells and capsule cells in the PNS)

  Reproductive Toxicity Studies

The two generation reproduction assay Designed to provide general information concerning the effects of a test substance on gonadal function, conception, parturition, and the growth and development of the offspring, these studies may also provide information about the effects of the test substance on neonatal morbidity, mortality, and preliminary data on teratogenegsis. They also serve as a guide for subsequent testing. Mating 3 week mating period Males sacrificed after 3 weeks, females sacrificed at weaning In-life observation Gross examination at least once daily, Physical or behaviour abnormalities recorded, Signs of difficult or prolonged parturition, all signs of toxicity, Duration of gestation from day 0 of pregnancy (vaginal plug or sperm counts) Litter examined for live pups, stillbirths, live births, sex and presence of gross anomalities, Live pups counted and litters weighed at birth and on day 4, 7, 14, 21, Necropsy A complete gross examination on all adult animals, Vagina, uterus, ovaries Testes, epididymides, seminal vesicles, prostate, pituitary gland

Histopathology Full histopathology of reproductive organs listed above All organs demonstrating a pathology during necropsy, Microscopic examination on all tissues showing gross pathological changes

  Developmental Toxicity Studies

Designed to provide general information concerning the effects of a test substance on in utero death, structural and functional abnormalities or growth retardation during the period of development, Weight of the gravid uterus, Examination of the uterus contents for embryonic or fetal deaths and the number of viable fetuses, Degree of resorption (estimate the relative time of death of the fetus), Number of corpora lutea for all species, except mice, Sex and weight of each fetus (weighed individually), Examination of the uterus contents for embryonic or fetal deaths and the number of viable fetuses, Examination of each fetus (externally and internally) for visceral and skeletal anomalities.

 

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