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Extraction of Essential Oil by Steam Distillation of Tulsi (Ocimum Basillicum)

Extraction of Essential Oil by Steam Distillation of Tulsi (Ocimum Basillicum)

Essential oils are insoluble in water and evaporate easily. We can obtain essential oil from plant tissues by distillation or extraction processes. Generally essential oils are obtain from every part of plant like stem, root, leaves, flowers, seed, branches etc. And these essential oils are used in the preparation of drugs, cosmetics and perfumes.
Holi Tulsi Plant
Ocimum Basillicum means Tulsi is an aromatic plant. Ocimum Basillicum is used to obtain essential oil useful for different application. This oil evaporates within 24 hours after applying it to our body. This essential oil helps in cure of digestion problem, strained muscles, headaches and nervous breakdowns. Due to its good medicinal properties and aroma its demand is very high in many countries. A person or company can build a small or large scale industry for the extraction of essential oil from Ocimum Basillicum (Tulsi).

Top 10 General qualitative properties of Ocimum Basillicum essential oil are given below-

essential oil extraction equipment photo1.  Appearance : Transparent fluid
2.  Color : Pale yellow
3.  Fragrance : Ocimum Basillicum’s distinctive flavor and fragrance
4.  Refractive Index on 20°C : 1.51200 to1.51900
5.  Specific Gravity on 25°C : 0.95200 to 0.97300
6.  Optical gyration on 25°C : [-] 8.85º to [-] 11.85º
7.  Well mixed with Hydroxycitronellal
8.  Insoluble in water
9.  Dissolved in paraffin oil

How to obtain oil from holi Tulsi plant?

The extraction of essential oil by steam distillation of ocimum basillicum (Tulsi) is a solid-liquid extraction process. This process completes in following steps-
Flow diagram of steam distilatillation
1.  Collect plant material and dry it if required.
2.  Fill this plant material in distillation vessel.
3.  Add water or solvent (like Ethanol, n-Hexane) in distillation vessel.
4.  Heat the mixture in well-equipped distillation vessel in control environment and controlled temperature, then
5.  Diffusion of essential oil from inside of solid material of plant to its surface occurs, then
6.  Transfer of mass from surface of plant solid material to surrounding liquid occurs, then
7.  This liquid contains essential oil which is obtained by reverse cooler.
8.  Then the collection of above liquid obtained from reverse cooler is put to stand for some time then essential oil come over water, then
9.  We perform layer separation to separate out essential oil from water, then
10.              Store this essential oil in dark, closed vessel for future use.
how to obtain Essential oil by steam distillation ?
The experimental results proves that yield of essential oil of Tulsi (Ocimum-Basillicum)  from only leaves of plant is slightly higher than from the mixture of leaves and stems (means plant crush).

MAIN REGULATORY BODIES AROUND THE WORLD FOR PHARMACEUTICAL PRODUCTS

MAIN REGULATORY BODIES AROUND THE WORLD FOR PHARMACEUTICAL PRODUCTS

Medicines are chemical or natural products used for healing, diagnosing, treating and improving health. These medicines contain API and Excipient. API is the main active drug which provide therapeutic effect and biologically active.  Excipient is non-active ingredient added in formulation along with API in medicine formulation.
Drugs or Medicines are very high importance as these are life saving, health improving, biologically active, provide therapeutic effect.   Drugs or Medicines provide adverse effect or lead to death if they are not manufactured with care and not manufactured in GMP (Good Manufacturing Practices) environment. Due to high risk, every country has its own regulatory body or regulatory authority. These regulatory bodies or regulatory authorities make and enforce rules and regulations and also prepare and issue guidelines for drugs or medicines manufacturing, licensing, registration, marketing, labeling and packaging of pharmaceutical products like tablets, injections, syrups, eye drops, ointment cream, spray, inhalers, liquid and OSD  (oral solid dosage) etc.
regulatory bodies for pharmaceutical products

List of Main Regulatory Authority around the World

Country
Name of  Regulatory Authority (Full and Short Form of Name)
USA
USFDA – Unites States Food and Drug Administration
UK
MHRA - Medicines and Healthcare Products Regulatory Agency
Australia
TGA - Therapeutic Goods Administration (TGA)
India
CDSCO - Central Drug Standard Control Organization (CDSCO)
Canada
TPD – Therapeutic Product Directorate
HPFBI – Health Product & Food Branches Inspectorate
Europe
EMA - European Medicines Agency
New Zealand
Medsafe - Medicines and Medical Devices Safety Authority
ANZTPA – New Zealand Therapeutic Product Authority
China
CFDA - China Food and Drug Administration
South Africa
MCC - Medicines Control Council
Sri Lanka
SPC – State Pharmaceutical Corporation, Ministry of Health
Brazil
ANVISA - Agencia Nacional de Vigiloncia Sanitaria
Vietnam
MOH - Ministry of Health
Malaysia
DCA – Drug Control Authority

Along with these Regulatory Bodies there are some international organizations also to control these pharmaceutical products like WHO (World Health Organization) and ICH (International Conference on Harmonization).
 

Media Filling Process

 Media Filling Process in Pharma Industry

Material issue as per FO (Formulation Order)
Material Verification
Media fill process
Material transfer into critical area (sterile lactose)
Liquid media preparation
Resealing of lactose bags
Check pH
Dispensing and blending with intervention simulation
Sterilize the m/c parts, rubber stoppers , dispensing aids, media garments and bin
m/c parts assembling ( filling) , bin , connection on the day of media filling
Media filling parts assembling and liquid media connection to filling m/c
Vial washing and sterilization

Media Checking for Growth

  •  Lactose and liquid media filling stoppering
  •  Sealing, crimping of aluminum seal ( sample for sterilize media for GPT, vials , rubber stoppers , compressed air sterility test / viable commit  monitoring)
  • Eternal vial washing m/c
  • Visual inspection m/c
  •  Online leak testing m/c
  •   Labeled tray with date / time and other details
  • Collect the vials in tray, transfer and handover to micro dept. for incubation through temp. controlled van (truck)

 Preparation of Media

·       Prepare 3% solution of media
·       30gm SCDM (soybean casein digest media) + 1000ml (qs) of wfi (Water For Injection) dissolve in glass carboy.
·       Collect the media sample for pH testing using pH meter and adjust the pH if require.
·       Labeled the media , date of preparation and exp date of media should be 7 days from the date of mfg (Manufacturing Date).
·       Plug the carboy with cotton plug and wrap with breathable cloth sterilize the carboy glass.
·       After sterilization unload the glass carboy in cooling zone and store under UAF on SS table (Stainless Steel Table).
·       Transfer the media carboy to vial filling room through the UAF mounted mobile trolley.
·       End of operation collect the media solution from each carboy and send to micro lab for GPT.
·       Incubate the media in micro lab for 7 days at 20C to 25C followed by 7 days at 30C to 35C.
·       Record the observation in microbiology validation green sheet.

GPT

          Growth Promotion Test, to insure that the liquid media used for the process simulation test is capable of microbial growth promotion.

Lactose Powder

                              Sterilized by gamma radiation method Lactose transfer in critical area
·       Gamma radiation sterilized powder of lactose => qc (quality Control) released => clean with lint free wipe
·       Outer carton and polybag removed in material transfer airlock
·       Pack sanitized and enter into pass box
·       Critical area
·       Lactose bags shall open inside the RABS (restricted access barrier system)

Dispensing Procedure

·       Lactose passes through mesh 36 over the ss-bin using the spoon
·       Load the bin on mixing column
·       Blend for 30 min
·       Unload the bin and transfer it into RABS
·       Remaining quantity also passed by same procedure
·       Quadruplet sampling carried out from 10 location (don’t take out sample only simulate)
·       Simulate pulled sample collection from 3 location (twice) for bulk analysis
·       Transfer the bulk containing lactose for vial filling operation

Assembling Vial Filling m/c Parts

·       Assembled the liquid media filling parts ( peristaltic pump with needles and silicon hose )
·       SS bin containing sterilize lactose
·       Upload it with lifting column
·       SS bin connect to powder hopper chute of vial filling m/c
·       Assembling the pre end post air flushing assembly
·       Insure that vials are flushed with sterile ( filtered ) compressed air during the filling process
·       30/40 ml vial – 50ml volume ( 250mg lactose) filled
·       100ml vial – 10ml volume ( 500mg lactose) filled
·       Minimum vial quantity to be put for incubation in each media fill operation shall not be less than 10,300 vials ( applicable for all pack sizes )
·       Record the collection time of media filled vials on each tray / boxes and affix the label

USE of Sterilize Lactose

·       Flow ability through the hopper and dosing wheel is similar to the product manufacture
·       It does not inhibit the growth of microbes and has growth promotion activity
·       Soluble in media and water
·       Sterilized by gamma radiation

Incubation Period

·       7 days ( bacterial growth ) – 20 to 25C
·       7 days ( viral growth ) – 30 to 35
·       Total 14 days incubation.
  
         1.  30/40ml vials 5500 to 6500 vials/hrs., lactose filled using single dosing mechanism      
            2. 100ml vials 2500 to 3500 double dosing wheel mechanism

Post Media-fill Activity

·       Clean and sanitize the equipment (used for media fill activity)
·       The final rinse sample (from product contact part) should be analyses for TOC
·       The TOC in the rinse water sample shall not exceed 500ppb
Vial
Stopper
Seal
30ml
20mm
20mm
40ml
20mm
20mm
100ml
28mm
28mm
Tubular vial
Bromobutyle rubber stopper
Flip off

Media-fill Failure

·       In case of media fill failure respective procedure of OOS ( out of specification) in microbiological analysis , investigation , deviation management shall be followed
·       Characterization of microorganism up to species level shall be carried out to find out the sources of contamination
·       Environmental records for manufacturing and testing area for temp. RH , DP and non-viable air born particle counts
·       Microbiological monitoring, reports of manufacturing and testing area for settling plate air sampling, surface monitoring and personnel monitoring.

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