Procedure for entry and exit in Manufacturing Area

Procedure for entry and exit in Manufacturing Area

Procedure

Entry in Manufacturing Area-I

Open the door of air lock of manufacturing area-I and enter into the air lock.

Take an apron from SS cabinet and wear it.

Ensure the nose mask & cap is wore.

Wear the hand gloves.

Disinfect hands with 70% IPA.

Open the door and enter in to manufacturing area-I.

Exit from Manufacturing Area-I.

Open the door and enter into the air lock.

Remove the apron and keep it in the “Used linen Bin”.

Open the door and exit from manufacturing area-I.

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Procedure for entry & exit in sterile area sterile area.

Procedure for entry & exit   in sterile area sterile area.

Precautions :

Among all the persons duly entered in sterile area, only

those whose names are laid down in the list are applicable for

this procedure.  Others are not permitted strictly.

Ensure about the overall cleanliness of change room.

Aware about the personal hygiene during all activities.

Do not touch any surfaces with hands.  Try to use elbow for pushing

the door during entry.

Do not make rapid movement.

Enter in to next change room only when the door of first one is closed.

Gowning procedure is strictly followed as per laid down sequence.

Try to Keep yourself inside the sterile area for half session of the work.

Avoid talking, if required use gestures preferably.

Entry Procedure :

Airlock – I

Open the door of Airlock – I and enter in to the Airlock – I

Take out your footwear meant for manufacturing premises and keep them on

the rack provided therein .

Remove the factory garments and keep it in the cupboard.

Push the doors slowly and take entry in air lock –II.

Airlock – II

Disinfect your hands with filtered 70% IPA.

Pick up a set of sterilized garments from cupboard having

Do the gowning strictly as per laid down sequence as mentioned below. While gowning the sterile dress should not touch to the floor.

Headgear      

Boiler suit (single piece)

Booties

footwear

Look at mirror for tidiness and neatness and then only enter in third air lock

by opening the door gently with the help of elbow. 

Airlock – III

In third air lock, disinfect your hands with filtered 70% IPA.

Pick up a set of sterile hand gloves and wear it properly.

Disinfect the hands again with filtered 70% IPA. Allow to dry.

Enter in sterile corridor by pushing the door with elbow.

Disburse according to your work allotment in sterile area of manufacturing premises.

Exit Procedure: 

Airlock – IV

   After completion of the job, open the door of fourth air lock and enter in           

Airlock – IV.

    Remove the used sterile garments as laid down sequence.

Hand gloves

Foot wear

Booties

Boiler suit

Head gear

and put them in the bag and discard the set of dress in the “Used Linen           

Bin” provided in fourth air lock.

 Open the door of 1^St air lock and enter in it.  Put on the factory garments and foot wears.

Open the door of corridor and come out in non sterile corridor.

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The procedure for performing Bubble point test.

 Procedure for performing Bubble point test.

Procedure

Precautions And Instructions:

Bubble point testing of membrane filter assembly should be performed before and after aseptic filtration of the solution by manufacturing chemist, and record there of should be maintained in the B.M.R.

Requirements:

                              Bubble point test assembly.

Procedures:

Remove the sterilized membrane filter assembly in sterile area.

Attach sterile silicon tubing at both ends.

Fill 2 liters sterile water for injection in bubble point test apparatus.

Attach upper end of silicon tube to the bubble point test apparatus and lower end to another sterile glass flask.

Filter 2 liters of sterile distilled water through membrane using Nitrogen pressure.

Remove the upper silicon tube and attach Nitrogen tube to the upper end of membrane holder.

Gradually increase the Nitrogen pressure up to 25 PSI  (1.5 lbs) and check for 30 seconds.

No bubble should come out from lower end of lower tube (which is dipped in the sterile distilled water) and there should be no fall in pressure, 

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CONCEPTS AND PRINCIPLES OF HOMEOPATHY

CONCEPTS AND PRINCIPLES OF HOMEOPATHY

        Hippocrates (460 BC -370 BC), the father of medicine, had insisted that the physician has to study the patient, not just illness. In treating patients, he should do everything to assist the nature, the great healer, to affect cure. He advocated similimum. Rig Veda, the source book from which ayurveda originated, states that ‘a cure for poison lies in the poison itself’.

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ANTI-TUSSIVES DRUG | VINCA-VASAKA LEAVES

Antitussives (Latin Tussis- cough) are the agents which act upon the pulmonary membrane that hasten or alter expectoration. These stimulate and expel the bronchial mucous or secretions and help in their removal.

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ANTI TUMOR DRUGS | VINCA AS A ANTI-TUMOR DRUG

ANTI TUMOR DRUGS

Antitumour (Latin : Tumor swelling, neoplasm) drugs are used in the treatment of cancer. The cancer or carcinogenic growth is an abnormal mass of new tissue growing in or on part of the body. Several types of carcinogenic growths have been reported. The cancer is regarded to be an incurable disease in secondary stages. The radioactive substances, metal compounds and several chemotherapeutic drugs have been suggested to control the carcinogenic growths.

The promising natural antitumour drugs or their isolates are obtained from the following:

Vinca : (Catharanthus roseus) Podophyllum : (Podophyllum hexandrum)
Colchicum : (Colchicum Iuteum) Benafsha : (Viola odorata)
Anacardium : (Semecarpus anacardium)

VlNCA
Synonyms : Catharanthus, Vinca rosea, Periwinkle

Biological Source: It is the dried whole plant of Catharanthus roseus 'G. Don., (syn vinca-roseai (Family : Apocynaceae).

Geographical Distribution:
It is probably indigenous to Madagascar. It is cultivated in South Africa, West indies, lndia, U.S.A., Europe and Australia as an ornamental plant, as well as, for its medicinal properties.

Organoleptic Characters (Fig) :
The leaves are green, roots are pale grey, flowers are violet, pink-white or carmine-red in colour. The odour is characteristic and taste is bitter. Vinca is an erect, pubescent herb, with branched tap-root. Leaves are simple, petiolate, ovate, or oblong, unicostate, reticulate, entire, brittle with acute apex and glossy appearance. Flowers are bractate,pedicellate, complete, hermaphrodite, normally 2 to 3 in cymose axillary clusters. Fruits are follicles with several black seeds.

VINCA ROSEA

VINCA FLOWER

Chemical Constituents :
Vinca contains wide varieties of chemicals including the glycosides and alkaloids. The indole~indoline alkaloids are very important constituents. About 60 alkaloids have been isolated so far from different parts of vinca. The important alkaloids with anticancer property are vincristine and vinblastine. Vincristine is obtained in about 0.0002 % yield from the crude drug. The other alkaloids present in the drug are ajmalicine, serpentine, lochnerine and tetrahydroalstonine. The total alkaloidal content of the drug is about 1 %, of which only a fraction contains therapeutically active alkaloids.

Both vinblastine and vincristine have the same structures with the difference that in vinblastine there is N-methyl group while, in vincristine it is N-formyl group and both Possess different activities. The other alkaloids are vindoline, vindolinine and catharanthine.

Uses:
Vincristine is used in treatment of leukaemia. Vinblastine is used for the treatment of generalised Hodgkin's disease and chorionepithelioma. Vinca also exhibits hypotensive and antidiabetic activity.

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GINGER

GINGER

Synonyms : Zingiber; Zingiberis, Sonth ,

Biological Source :
Ginger consists of rhizomes of Zingiber officinale Roscoe, Family : Zingiberaceae, scrapped to remove outer skin and dried in sun. It contains not less than 0.8% of total gingerols on dried basis.

Geographical Distribution :
it is said to be native of South East Asia, but is cultivated in West Indies, Africa, Australia, Mauritius, Jamaica, Taiwan and India. More than 50 % of the world's
production is from lndia.

Organoleptic Characters
Colour : Externally, it is buff coloured,

Odour : Aggreeable and aromatic.

Taste : Aggreeable and pungent. Size : Rhizomes of ginger are about 5 to 15 x 1.5 to 6.5 cm.

Shape : Rhizomes are laterally compressed bearing short flat, ovate and oblique branches on the upper side, with bud at the apex.

T.S OF GINGER

ZINGER OFFICINALE

Fracture '. Short and fibrous.
 Uses :
Ginger is used as a stomachic, an aromatic, a carminative, stimulant and flavouring agent. Ginger oil is used in mouth washes, ginger-beverages and liquors.

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FENNEL SEED

FENNEL

Synonyms: Fennel fruits, Fructus Foeniculum, Saunf

Biological Source:  Fennel consists of dried ripe fruits of the plant known as Foeniculum vulgare Miller(Family : Umbelliferae) obtained by cultivation. It should contain not less than 1.4 % of volatile oil.
Geographical Distribution : It is indigenous to Mediterranean countries and largely cultivated in Rumania, Russia, Germany, France, India and Japan.In India it is cultivated in Gujarat, Punjab, Maharashtra, Rajasthan, Uttar Pradesh and West Bengal.
Organoleptic Characters : Colour : Green to yellowish-brown.
                                              Odour : Sweet aromatic.
                                              Taste : Strongly aromatic and mucilaginous.
                                              Size : 5 to 10x 2 to 4mtn.
                                              Shape : Straight or slightly curved

 

T.S of mericarp of fennel 

Chemical Constituents : Fennel consists of 3 to 7 % of volatile oil about 20% each of proteins and fixed oil. The chief active constituent of volatile oil is a ketone, fenchone (about 20%) and a phenolic ether, anethole (about 50 %). The other constituents are phellandrene, Limonene, methyl chavicol, anisic aldehyde etc. Fenchone is a colourless liquid with pungent odour. The anethole is sweet in odour and taste.

Uses : 

It is used as a carminative, an aromatic and a stimulant. It is also an expectorant.  Pharmaceutically it is used as a flavouring agent.

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CINNAMON STICK

CINNAMON

Synonyms: Cinnamon bark; Kalmi-Dalchini, Ceylon cinnamon 

Biological Source :
Cinnamon consists of dried inner bark of shoots of coppiced trees of Cinnamomum zeylanicum Nees belonging to family Lauraceae. lt should not contain less than 1.0 % of volatile oil.

Geographical Distribution :

Cinnamon, the evergreen tree of tropical area is considered to be native of Sri Lanka and Malabar coast of lndia. lt is also found in Jamaica and Brazil. However, most of the world requirements are met by Sri Lanka and hence true cinnamon is known as I Ceylon cinnamon.

Chemical Test: 

On addition of a drop of ferric chloride solution to a drop of volatile oil, a pale green colour is produced. With ferric chloride, cinnamic aldehyde gives brown colour and eugenol gives blue colour, resulting in formation of pale green colour. 

in cassia oil, brown colour is obtained, as it contains only cinnamic aldehyde . 

Uses: 

Bark is used as a carminative, stomachic and mild astringent. It is also used as a flavouring agent, stimulant, an aromatic and antiseptic. Commercially, it is used as a spice and condiment, and also in the preparation of candy, dentifrices and perfumes. 

Colour : The outer surface is dull yellowish-brown, while the inner surface is dark yellowish-brown.

Odour : Aromatic, sweet followed by warm sensation.

Taste : Found in the form of compound quills. . ,

Size : About 1 m in length and 1 cm in diameter. The thickness of the bark is approximately 0.5 mm.
Fracture : Splintery. 

CINNAMON STICK

CINNAMON LEAF

Chemical Constituents :

Cinnamon bark contains about 0.5 to 1.0 % of volatile oil, 1.2 % of tannins

(phlobatanmns), mucilage, calcium oxalate, starch and a sweet substance known as mannitol. .

Bark yields 14 -16 % of 90 % alcohol-soluble extractives.

The volatile oil is the active constituent of the drug. lt is light yellow (when freshly distilled) in colour and changes to red on storage.

Cinnamon oil contains 60 7O % cinnamaldehyde, 5 10 % eugenol, benzaldehyde, cuminaldehyde and other terpenes like phellandrene, pinene, cymene, caryophyllane etc.

Chemical Test:
On addition of a drop of ferric chloride solution to a drop of volatile oil, a pale green colour is produced. With ferric chloride, cinnamic aldehyde gives brown colour and eugenol gives blue colour, resulting in formation of pale green colour.

in cassia oil, brown colour is obtained, as it contains only cinnamic aldehyde .

Uses:
Bark is used as a carminatiye, stomachic and mild astringent. It is also used as a flavouring agent, stimulant, an aromatic and antiseptic. Commercially, it is used as a spice and condiment, and also in the preparation of candy, dentifrices and perfumes.

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