4.
Vibration : May occur during transport and may lend to removal of the
label, seggregation of powders, or cracking of emulsions.
.و اٌَّزؾٍجبد١َ رىٚك أ١ رفىه اٌَّبؽٚ اىاٌخ اٌٍّظك أٌٝ اٞئك٠ ّْىٓ أ٠ٚ ًؾلس أصٕبء إٌم٠ لل:اال٘زياى
[2].. Environmental hazards: انمخبطر انجُئُخ
1. Temperature كهعخ اٌؾواهح
2. Pressure اٌؼغؾ
3. Moisture ثخٛاٌوؽ
4. Gases اٌغبىاد
5. Light ءٛاٌؼ
6. Infection االطبثخ
Properties of Package Materials: خصبئض مىاد انتعجئخ وانتغهُف
1- Mechanical properties : انخىاص انمُكبوُكُخ
It should be stròng enough to withstand handling, filling, processing (labelling,
sterilization), transport, storage and use by the consumer.
َاالٍزقلاٚ ٓ٠اٌزقيٚ ًُ)إٌم١اٌزؼمٚ ٌٍُٛاٌّؼبٌغخ (اٚ اٌزؼجئخٚ ٌخٚ ٌزؾًّ إٌّبٟىف٠ خ ثّب٠ْٛ لٛغت أْ رى٠
.ٍهِٙٓ لجً اٌَّز
2 - Physical properties: انخصبئض انفُسَبئُخ
1- The material should be non-Porous. خ١ِو َِب١ْ اٌّبكح غٛأْ رى
2- Must able to withstand heat during sterilization. ُ١زؾًّ اٌؾواهح أصٕبء اٌزؼم٠ ْغت أ٠
3- The surface must be capable of labelling- (difficult with Plastic)
)ه١ (طؼت ثبٌجالٍز- ػغ اٌؼالِخٌٛ ًْ اٌَطؼ لبثالٛى٠ ْغت أ٠
4- The material should protect the drug from light, ِٓ اءٚ اٌّبكح اٌلّٟغت أْ رؾ٠
ءٛاٌؼ
5- Must have long life. ً٠ٛزّزغ ثؼّو ؽ٠ ْغت أ٠
6- Must not absorb water. ّزض اٌّبء٠ غت أال٠
3. Chemical Properties: انخصبئض انكُمُبئُخ
1-It must not react with the product and vice versa. ؼ١اٌؼىٌ طؾٚ زفبػً ِغ إٌّزظ٠ أال
2- Must not abstract substance from contents. بد٠ٛل اٌّبكح ِٓ اٌّؾز٠غت ػلَ رغو٠
3- The container or the closure must not yield substances to the product. e.g. alkali
from glass or plasticizer from plastics.
ِٓ اٌٍّلٔبدٚبد ِٓ اٌيعبط أ٠ًٍٛ اٌّضبي اٌم١ ٍجٍٝ ػ.اك ٌٍّٕزظِٛ اإلغالقٚخ أ٠ٕٚزظ ػٓ اٌؾب٠ غت أال٠
.ه١اٌجالٍز
Labelling : وضع انعالمبد
Drug labelling includes خ٠ٚطف األكٚ ًّش٠
1. Labelling on the container and package. اٌوىِخٚ حٛ اٌؼجٍٝاٌٍّظك ػ
2. Leaflet (Pamflet) inside the product. ٔشوح (ثبِفٍذ) كافً إٌّزظ
3. Literature
4. Advertising papers for promotion of marketing ك٠َٛظ ٌٍز٠ٚخ ٌٍزو١هاق كػبئٚأ
5. Catalogues عبدٌٛاٌىزب
6. Films.
The outside label should contain the following: ًَدت أن َحتىٌ انمهصك انخبرخٍ عه
ٍمب َه
1) Pharmaceutical dosage form. خ١ائٚشىً عوػبد ك.
2) The usual dose of the product. اٌغوػخ اٌّؼزبكح ٌٍّٕزظ.
4) Storage conditions. ٓ٠ؽ اٌزقيٚشو.
4) Batch number. هلُ اٌلفؼخ.
5) Warnings (for some habitual drugs) )خ اٌّؼزبكح٠ٚواد (ٌجؼغ األك٠اٌزؾن
Storage : انتخسَه
The product sbould be stored under proper conditions. The terms on the label
should be well understood.
ِخٛٙ اٌٍّظك ِفٍٝكح ػٛعٌّْٛ اٌّظطٍؾبد اٛغت أْ رى٠ .ف ِٕبٍجخٚ ظً ظوٟٓ إٌّزظ ف٠غت رقي٠
.لًا١ع
Cold : not exceeding 8°c
خ٠ٛ كهعبد ِئ8 ٓل ػ٠ي٠ ال:ثبهك
A refrigerator maintains : the temp. 2 -8°c كهعخٍٝاٌضالعخ رؾبفع ػ
خ٠ٛ كهعخ ِئ8-2 .اٌؾواهح
A freezer has a temp. - 10 and 20°c ٗ كهعخ٠يه ٌل٠اٌفو
خ٠ٛ كهعخ ِئ20 ٚ 10 غوفخ- .ؽواهح
room Temperature : 15 - 30°c
خ٠ٛ كهعخ ِئ30 - 15 : كهعخ ؽواهح اٌغوفخ
Warm : 30- 40°c
خ٠ٛ كهعخ ِئ40-30 :كافئ
Excessive Heat : above 40°c
خ٠ٛ كهعخ ِئ40 قٛ ف:اٌؾواهح اٌيائلح
Definitions
1- The large scale manufacturing operations of (starting and/or final)materials to
produced pharmaceuticals in active and conformable form ,with acceptable test
& odor and without impurities and side effects with examination of these
products during their storing
ٟخ إٌّزغخ ف١ٔلال١ اٌَّزؾؼواد اٌظٌٝاك اٌّٛخ) ا١بئٙٔ ٚ أ/ ٚ خ٠اٍؼخ إٌطبق ِٓ (ثلاٚ غ١ٕبد اٌزظ١ٍّػ
خ ِغ فؾض ٘نٖ إٌّزغبد أصٕبء١آصبه عبٔجٚ ائتْٛ شٚثلٚ ٓ١ٌزٛهائؾخ ِمجٚ ِغ افزجبه، ِطبثكٚ شىً ٔشؾ
بٕٙ٠رقي
2- The large scale manufacturing operations( mixing ,size reduction ,extraction, s
drying, size separation, distillation ,evaporation...etc)of pharmaceuticals (
liquids, powders ,capsules ,lablets injections ,ointments...etc) using
development equipment's.
، و١ اٌزمط، ُ اٌفظً ثبٌؾغ، ف١ اٌزغف، االٍزقواط، ًُ اٌؾغ١ٍ رم، اٍؼخ إٌطبق (اٌقٍؾٚ غ١ٕبد اٌزظ١ٍّػ
اٌـ) ثبٍزقلاَ ِؼلاد... ُ٘ ِوا، ؽمٓ ِقزجواد، الدَٛ وج، ك١ َِبؽ، ًائٍٛ( خ٠ٚ اٌـ) ٌألك... اٌزجقو
.و٠ٛاٌزط
The reasons for large scale : أسجبة انحدم انكجُر
1. Economy The production costs decrease as the manufacturing batches increase
,and the use of mechanical equipment's increase the efficiency.
.ل ِٓ اٌىفبءح٠ي٠ خ١ى١ٔىب١ٌّاٍزقلاَ اٌّؼلاد اٚ ، غ١ٕبكح كفؼبد اٌزظ٠ف اإلٔزبط ِغ ى١ٌ رٕقفغ رىب:االلزظبك
2. Accuracy As the quantity of materials becomes larger the accuracy increase.
.اك ىاكد اٌللخٌّٛخ ا١ّاٌللخ وٍّب ىاكد و
3. Greater scope It is very difficult to produce new complex modern drugs in
small scale because these need:
:ٌٝخ رؾزبط ا٠ٚك ألْ ٘نٖ األك١ ٔطبق ػٍٝلح ػ٠ِؼملح علٚ ضخ٠و ؽل١خ أزبط ػمبل٠ٔطبق أوجو ِٓ اٌظؼت ٌٍغب
a. Large organization وح١ِٕظّخ وج
b.Advanced staff َك ػًّ ِزمل٠فو
C. Good facilities ) ِظٕغٚ اءٚلح (ك١اطفبد عِٛ
d. Wide marketing اٍغٚ ك٠َٛر
Break down of processes اوهُبر انعمهُبد
Pharmaceutical industry requires wide range of machines:
:الد٢اٍؼخ ِٓ اٚ ػخّٛخ ِغ١ائٚرزطٍت اٌظٕبػخ اٌل
It requires many pipes carrying services such as: ٟت اٌز١ل ِٓ األٔبث٠ب رزطٍت اٌؼلٙٔا
ًرؾًّ فلِبد ِض
1-Water اٌّبء2-Steam اٌجقبه3-compressed air ؽٛاء اٌّؼغٌٛٙا
Pharmaceutical products includes: تشمم انمىتدبد انصُذالوُخ
1-Liquids ًائٌَٛ ا2-Powders لبدٛاٌَّؾ3-Capsules الدَٛاٌىج
4-Tablets االلواص5-Injections ٓاٌؾم 6-Ointments ُ٘اٌّوا
In plant manufacturing three different forms of pharmaceutical products:
فٍ مصىع انتصىُع ثالثخ أشكبل مختهفخ مه انمىتدبد انصُذالوُخ
1- Mixed powders ك ِقزٍطخ١َِبؽ
2 - Compressed tablets ؽخٛألواص ِؼغ
3-Dry extracts َِزقٍظبد عبفخ
And the general operations In plant manufacturing involved:
ٍوتشتمم انعمهُبد انعبمخ فٍ انتصىُع انمصىع عهً مب َه
1-Mixing اٌقٍؾ2-Drying ف١اٌزغف3-Extraction االٍزقواط4-Distillation
و١اٌزمط
5-Evaporation و١اٌزجق6-Size separation ًؽغُ اٌفظ7-Size reduction و١رظغ
ُاٌؾغ
BUT: The individual operations In plant munufacturing involve: The
operations involve in manufacturing of mixed powder
تشتمم انعمهُبد عهً تصىُع مسحىق مخهىط: ٍ تشمم انعمهُبد انفردَخ فٍ تصىُع انمصىع مب َه:ونكه
1)Size reduction ُو اٌؾغ١رظغ2)Size separation ُفظً اٌؾغ3)Mixing
اٌقٍؾ
4) The operations in manufacturing of compressed tablets involve
ؽخٛغ األلواص اٌّؼغ١ٕبد رظ١ٍّرشًّ ػ
1. mixing اٌقٍؾ2-size reduction ُو اٌؾغ١رظغ
3-drying ف١اٌزغف4-Size separation . ُفظً اٌؾغ
The operations involve in manufacturing of dry Extract
تشمم انعمهُبد تصىُع انمستخهض اندبف
1-mixing اٌقٍؾ2-size reduction ُو اٌؾغ١رظغ3-extraction االٍزقالص
4- drying ف١ اٌزغف5- distillation و١اٌزمط6- evaporation و١اٌزجق
{3 +4 +7} individual operations =(7} general operations11
Basis af unit operation: أسبش تشغُم انىحذح
1.Fluid flow ًٍوػخ رلفك اٌَبئ
2. Heat transfer أزمبي اٌؾواهح
3. Mass transfer ) ي اٌؾبٌخٛأزمبي اٌىزٍخ (رؾ
Fluid Any liquid , vapor or gas pass through pipes, channels or between particles
ّبد١َٓ اٌغ١ ثٚاد إٔٛ اٌمٚت أ١ّو ػجو األٔبث٠ غبىٚ ثقبه أٚ ٍبئً أٞ أ:ًاٌَبئ
Mechanism of fluid flow آنُخ تذفك انسىائم
Reynold Experinment تدرثخ رَىىنذ
Aim of Experiment : انهذف مه انتدرثخ
To explain the character of fluid flow through a pipe or channel
اٌمٕبحٚة أٛائً ػجو األٔجٌَٛؼخ رلفك ا١ٌشوػ ؽج
Equipment's
1. constant heat of water ٓ اٌّبء اٌَّزّو١رَق2. dye solution يٍِٛؾ
اٌظجغخ
3. long glass tube ً٠ٛ ؽٟة ىعبعٛأٔج4. flow control ٍٝطوح ػ١ٌَا
ٍٍوػخ اٌزلفك
Work: ًّاٌؼ
1-Streamline flow ئ١رلفك ثط2-Transitional flow ٌٟاٌزلفك االٔزمب3-Turbulent flow
اٌزلفك اٌّؼطوة
Results of experiment: وتبئح انتدرثخ
Reynold found that fluid flow condition, where effect by:
ش رئصو ِٓ فالي١ ؽ، ًائٌٌَٛل أْ ؽبٌخ رلفك إٛ٠عل هٚ:
1. Pipe diameter D ةٛلطو األٔج
2. Fluid velocity V ًٍوػخ اٌَبئ
3. Fluid density P ًائٌَٛوضبفخ ا
4. Fluid viscosity M ًائٌَٛعخ اٌٚي
5. Reynold Number R. ٌلٕٛ٠هلُ ه
Renold law ..... R = PVD/M
Heat transfere اوتمبل انحرارح
Process by which energy in the form of heat is exchanged hetween bodies or parts
of the same body at different temperatures.
أعياء ِٓ ٔفٌ اٌغَُ ػٕل كهعبد ؽواهحٚٓ أعَبَ أ١ شىً ؽواهح ثٍٝب رجبكي اٌطبلخ ػٌٙزُ ِٓ فال٠ خ١ٍّػ
ِقزٍفخ.
Methods of heat transfere ؽوق ٔمً اٌؾواهح
Heat can be transferred by three processes: بد١ٍّّىٓ ٔمً اٌؾواهح ثضالس ػ٠
1_conduction ً١طٛاٌز
2_ convection ٞاٌؾًّ اٌؾواه
3_ radiation االشؼبع
Transitions of heat in industrial processes ٍاوتمبالد انحرارح ف
انعمهُبد انصىبعُخ
1-Transition of solid to liquid تحىل انصهت انً سبئم
Using of hot plate ,immersion, mental or mental strip heater or cold plate
immersion cooler to
i- Heating or cooling of any sol. ًائٍٛ ٞل أ٠ رجوٚٓ أ١رَق
ii-Evaporation of solvents. جبد٠رجقو اٌّن
iii-Drying of sol. ًائٌَٛف ا١رغف
2-Transition of liquid to liquid. تحىل انسبئم انً انسبئم
Using of water ,oil .
3- Transition of gas to liquid. تحىل انغبز انً انسبئم
Using of nitrogen or ammonia to cooling the solutions directly by bubbling or
indirectly by condensation.
Mass Transfere. اوتمبل انكتهخ
Is the transition of material from one phase to another ٌٝه اٛأزمبي ٌّبكح ِٓ ؽ
افو
Example 1
1. In distillation the liquid converted to vapor then to liquid to purification.
خ١ ٍبئً ٌزٕمٌٝ ثقبه صُ اٌٝي اٌَبئً اٛزؾ٠ و١ اٌزمطٟف.
2. Extraction solid material is converted to solution them to solid for purification.
خ١ طٍت ِٓ أعً اٌزٕمٌٝي اٍٛ ِؾٌٝاك اٌظٍجخ اٌَّزقوعخ اًٌّٛ ا٠ٛزُ رؾ٠.
Liquid's states :
1. Aqueous ِٟبئ2-Oily ٟز٠ى3-Colloidal ٞٚغو
4-Suspension ِؼٍك5-Emulsion َِزؾٍت
Solid's states:
1- Precipitate هاٍت2-powder كهحٛث3-slurry ٓ١ؽ
4-crystal َزبي٠وو5-granules جبد١ ؽج6-gelatin ٓ١عالر
