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\def\citeauthor{~Rajaguru~R,
              ~Shalini~G,
              ~Sai~Priya~R,
              ~Sutheesh~T,
              ~Naveen~Kumar~P}
\def\citetitle{Comparison of Process Parameter of Lab Batches, Scale-Up Batches Exhibit Batches Commercial Batches}
\def\copyrightstmt{This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial- ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.}
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\def\RunningAuthor{Rajaguru R et al.}
\firstPage{123}
\articleType{Original Article}
\receivedDate{02 Jun 2021}
\acceptedDate{13 Jun 2021}
\revisedDate{12 Jun 2021}
\journalVolume{1}
\journalIssue{3}
\journalDoi{fjphs.v1i3.220}
\copyrightYear{2021}
\eISSN{2583-116X}
\journalDoi{fjphs.v1i3.220}
\def\authorCount{5}
\def\affCount{4}

\def\journalTitle{Future Journal of Pharmaceuticals and Health Sciences}

\title{Comparison of Process Parameter of Lab Batches, Scale-Up Batches Exhibit Batches Commercial Batches}
\author{Rajaguru~R\textsuperscript{*}\textsuperscript{1},  
            Shalini~G\textsuperscript{2},  
            Sai~Priya~R\textsuperscript{3},  
            Sutheesh~T\textsuperscript{4}, 
            Naveen~Kumar~P\textsuperscript{4}~\\[5pt]{\textsuperscript{1}Research Scholar, Department of Pharmaceutics, GITAM University Rudraram, Patancheru Mandal, Telangana, Hyderabad-502329, Telangana, India}~\\{\textsuperscript{2}Department of Bioinformatics, The Tips Global Institute affiliated to Bharathiar University, Coimbatore{\textendash}641046, Tamil Nadu, India}~\\{\textsuperscript{3}Department of Bioinformatics, Bharathiar University, Coimbatore{\textendash}641046, Tamil Nadu, India}~\\{\textsuperscript{4}Department of Pharmacy, Malla Reddy Institute of Pharmaceutical Sciences, Maisammaguda, Dhulapally, Post Komapally, Medchal Mandal, Secunderabad- 500100, Telangana, India}}

\begin{abstract}
The aim of the present work is to evaluate the critical process parameters and techniques and improve the quality and reduce cast and scaling up time. The pharmaceutical industry R \& D refers to the process of successful progress from drug discovery to product development. The need to the target market are identified alternative product concept are generated and evaluate and single concept of selected for future development. The concept is a description of the from function and features a product and a usefully. The Scale up is the process as define to increasing the batch size or increasing different physical parameter the output of volume. The old process scale up techniques doesn't involve studying the critical process parameters (Raw Process). The scale up batches industry to improve quality of the product in moving from Scale up batches/Exhibit Batches and validation batches. To improve the batches quality scale up of a process Transformation of small scale lab batches into commercial scale depended on experience and probability and involving the more technique. Due to this probability of success is less understanding of critical process parameters and process enables control of critical step process parameter during manufacturing and successful transformation from lab scale to Exhibit batches and commercial batches.
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Scale up,\newline Exhibit Batch Validation,\newline Commercial Batches,\newline R\&D Process
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright{\Large$^\ast$}Corresponding Author\par Name:\ Rajaguru~R~\\ Phone:\ +91 80985 32413~\\  Email:\ rajaguru94mrv@gmail.com
        \par}\vspace*{-13pt}\hrulefill\par\ifx\@eISSN\@empty\else{\fontsize{12}{14}\selectfont eISSN: \@eISSN\hfill pISSN: \@pISSN}\par\fi% 
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        \makeatother
        
    
\section{Introduction}
Historical data shows that the R\&D Expenditure in pharmaceutical firms, which is between 14\% and 18\% of their annual sales. Is about five times more than average R\&D Expenditure in others industries. The pharmaceutical industry R\&D refers to the process of successful progress from drug discovery to product development. The scale up batches industry to improve quality of the product in moving from Research and Development (R\&D) to production, Scale up batches/Exhibit Batches and validation batches to improve the batches quality scale up of a process can also be viewed as a procedure for applying the same process to different output volumes \unskip~\cite{1120148:22369913}. Transformation of these small-scale up observations into the large-scale development mostly requires entirely varied design strategies and equipment which may result in differences in quality. The process of new product development is based on cooperation between designers, different department of the company and suppliers and clients. The process consists of four stages.


  
  \begin{enumerate}
  \item \relax Stages I~{\textendash} Feasibility study; this stage lasts from 2 to 5 weeks.
  \item \relax Stages II {\textendash} Design phase; This phase can lasts up to 6 months. 
  \item \relax Stages III {\textendash} Preparation of the prototype, Final costs and price estimation this stage lasts up to 5 months. 
  \item \relax Stages IV {\textendash} Manufacturing.
  \end{enumerate}
  The novel stage of Scale-up is defined as the process of increasing batch size [Table~\ref{tw-79649d98c464}]. Scale-up of a process viewed as a procedure for applying the same process to different output volumes. There is a subtle difference between these two definitions: batch size enlargement does not always translate into a size increase of the processing volume \unskip~\cite{1120148:22369905}.

\textbf{Concept of Product Development}

The need to the target market are identified alternative product concept are generated and evaluate and single concept of selected for future development. The concept is a description of the from function and features a product and a usefully [Figure~\ref{f-35c58305e1c2}].
    
\section{METHOD}
The current procedure of process of exhibit batches depends on country to country and followed the various processes.

\textbf{In United States}


  
  \begin{enumerate}
  \item \relax R\&D Trial batches
  \item \relax Lab scale up batches
  \item \relax Process batches/Exhibit batches/Submissition batches
  \item \relax Pivotal batches/Exhibit/Submission batches
  \item \relax Process validation batches (Divided into three batches) \unskip~\cite{1120148:22369912}. 
  \end{enumerate}
  \textbf{In Japan States}


  
  \begin{enumerate}
  \item \relax R\&D Trial batches
  \item \relax Dissolution method development
  \item \relax Lab scale up batches
  \item \relax ProcessOptimization batches/ Trial batches
  \item \relax Pivotal batches/Exhibit batches/Submission batches
  \item \relax Process validation batches (Divided into three batches first batch accidental second batches quality is regulatory quality third batches is validation) \unskip~\cite{1120148:22369922}.
  \end{enumerate}
  \textbf{Selection and Function of Raw Materials}

The raw material is basic excipients with a mycophenolate mofetil tables are prepared. It is procured form other company and depends upon the grade \& quality [Tables~\ref{tw-de726dcddfa4} and~\ref{tw-8e3fe38ae127}].

\textbf{Precaution}

Mycophenolate Mofetil is used as immunosuppression agent use nose mask hand gloves and respirator during processing to avoid exposure to powder inhalation.

\textbf{Mycophenolate}

Mycophenolate Mofetil is the 2-morpholinoethyl ester of Mycophenolic acid (MPA), an Immunosuppressive agent inosine Monophosphate dehydrogenase (IMPDH) inhibitor [Figure~\ref{f-ce4d23006446}] [Table~\ref{tw-63818b6b4103}] \unskip~\cite{1120148:22369914}.

\textbf{The raw material is basic excipients with a Mycophenolate Mofetil Microcrystalline}

\textbf{Cellulose}

Microcrystalline cellulose grades used in the formulation development are (Avicel PH101) and (Avicel PH 102). These excipients are generally recommended as diluent microcrystalline cellulose grades use of the tablets diluent of concentration 20-90\% using in microcrystalline cellulose grades is incompatible with strong oxidizing agents \unskip~\cite{1120148:22369917}.

\textbf{Croscarmellose Sodium}

Croscarmellose sodium (Ac-Di-Sol) used in the generally recommended as disintegrant Croscarmellose sodium id disintegrant in tablets 0.5-5.05 using. Croscarmellose sodium is a stable though hygroscopic material.

\textbf{Povidone}

Povidone K 90 was selected in the formulation it is used in the formulation as a binder 0.5-5.0\% povidone is suspending agent upto 5.05\%.

\textbf{Magnesium Stearate}

Magnesium stearate was selected as lubricant it is used as a lubricant in tablets manufacture at concentration between 0.25-5.0\% using.

\textbf{Opadry Purple}

It is a ready-mix grade of film coating composition supplied from colorcon. This coating material is recommended as Non- functional film coating in the immediate release tablets dosage forms and it contains HPMC29/10 Hypromellose and hydroxypropyl cellulose as a film former, polyethylene glycol as plasticizer and titanium oxide as opacifier FD \& C Blue 2 is permitted in the United States indigo carmine Aluminium 3\% -5\% and iron oxide red as colorants. 

\textbf{Manufacture Procedure }

\textbf{Dispensing}

In this the raw material of mycophenolate mofetil \& excipient is dispensed to prepare mycophenolate mofetil tablets of dispense product depend upto batch size\textbf{\space }\unskip~\cite{1120148:22369921,1120148:22369909}.

\textbf{Sifting}

Microcrystalline cellulose (Avicel PH 101) through mesh \# 40

Croscarmellose sodium (Ac-di-Sol) through mesh \# 40 \unskip~\cite{1120148:22369919}.

\textbf{Preparation of Binder Solution}

Weight quality of purified water in a S.S (Plasdone K-90) slowly to the purified water of while stirring and continue the clear solution is obtained \unskip~\cite{1120148:22369908,1120148:22369911}.

\textbf{Dry mixing}

Transfer Mycophenolate Mofetil \& sifted material of into rapid mixer granulator and mix for 10 minute with impeller at slow speed and chopper off and record the amperage reading of impeller motor \unskip~\cite{1120148:22369920}.


\begin{table*}[!htbp]
\caption{\boldmath {Pharmaceutical formulation and process can be designed using the following statistical tools} }
\label{tw-79649d98c464}
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\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack  & \cAlignHack Desired Product Quality & \cAlignHack \\
\tblmidrule 
\cAlignHack ICH Q8 (R2) Pharmaceutical  \mbox{}\protect\newline Development &
  \cAlignHack ICH Q9 quality risk  \mbox{}\protect\newline Management &
  \cAlignHack ICH Q10 Pharmaceutical  \mbox{}\protect\newline Quality systems\\
\tblbottomrule 
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\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Regulatory Authority} }
\label{tw-de726dcddfa4}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.24490000000000002\linewidth-2\tabcolsep}p{\dimexpr.2553000000000001\linewidth-2\tabcolsep}p{\dimexpr.4998\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Country & \cAlignHack Regulatory Authority & Full Name\\
\tblmidrule 
\cAlignHack India  &
  \cAlignHack CDSCO  &
  Central drugs standard control organization \\
\cAlignHack USA  &
  \cAlignHack USFDA  &
  Food and drug administration \\
\cAlignHack Canada  &
  \cAlignHack HC  &
  Health Canada \\
\cAlignHack Europe  &
  \cAlignHack EMEA  &
  European medicine agency \\
\cAlignHack UK  &
  \cAlignHack MHRA  &
  Medicines and Healthcare products regulatory agency \\
\cAlignHack Japan  &
  \cAlignHack PMDA  &
  Pharmaceuticals and medical devices agency \\
\cAlignHack Russia  &
  \cAlignHack MOH  &
  Ministry of Health \\
\cAlignHack Brazil  &
  \cAlignHack ANVISA  &
  Ministry Sanitary Surveillance Agency \\
\cAlignHack Indonesia  &
  \cAlignHack NADFC  &
  National agency of drug and food control of republic of  \mbox{}\protect\newline Indonesia \\
\cAlignHack South Africa  &
  \cAlignHack MCC  &
  Medicine control authority \\
\cAlignHack Thailand  &
  \cAlignHack FDA-Thailand  &
  Food and drug administration Thailand \\
\cAlignHack China  &
  \cAlignHack SFDA  &
  State food and drug administration \\
\cAlignHack Singapore  &
  \cAlignHack HAS  &
  Health sciences authority \\
\cAlignHack Malaysia  &
  \cAlignHack DCA  &
  Drug control authority \\
\cAlignHack Philippines  &
  \cAlignHack BFDA  &
  Bureau of food and drug administration \\
\cAlignHack Srilanka  &
  \cAlignHack MOH  &
  Ministry of health \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Selection of Excipients} }
\label{tw-8e3fe38ae127}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.6556\linewidth-2\tabcolsep}p{\dimexpr.34440000000000005\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Excipient  & Category \\
\tblmidrule 
\multicolumn{2}{p{\dimexpr(1\linewidth-2\tabcolsep)}}{\textbf{Tablets Core}}\\
Mycophenolate Mofetil USP  &
  API \\
Microcrystalline cellulose (Avicel PH101)  &
  Diluent \\
Microcrystalline cellulose (Avicel PH102)  &
  Diluent \\
Croscarmellose sodium (Ac-di-sol)  &
  Disintegrant \\
Povidone (Plasdone K-90)  &
  Binder \\
Magnesium stearate (LIGAMED MF-2-V)  &
  Lubricant \\
\multicolumn{2}{p{\dimexpr(1\linewidth-2\tabcolsep)}}{\textbf{Coating}}\\
Indigo carmine lacquer  &
  Colorant \\
Hydroxypropyl cellulose  &
  Film forming agent \\
Hydroxypropyl methyl cellulose  &
  Film forming agent \\
Polyethylene glycol 400  &
  Plasticizer \\
Red iron oxide  &
  Colorant \\
Titanium dioxide  &
  Opacifying agents \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Chemistry of Mycophenolate Mofetil USP} }
\label{tw-63818b6b4103}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.3007999999999999\linewidth-2\tabcolsep}p{\dimexpr.6992\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Details & Description\\
\tblmidrule 
Description  &
  White or almost white crystalline powder. \\
Structure  &
  [Figure~\ref{f-ee1025675581}]\\
Chemical name  &
  2-(Morpholin-4-yl)ethyl(4E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3- dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate. \\
Molecular formula  &
  C23 H31 NO7 \\
Molecular weight  &
  433.50 \\
Solubility  &
  Freely soluble in acetone, sparingly soluble ethanol and slightly soluble in water \\
Polymorphism  &
  It does not show polymorphism \\
Melting point  &
  Between 94\ensuremath{^{0}}C and 98\ensuremath{^{0}}C \\
 ka  &
  5.6 \\
Therapeutic category  &
  Immunosuppression agents \\
Pharmacopoeia status  &
  Drug substance and drug product both are official in USP \\
BSC Classification  &
  Class-II (Low solubility and High permeability) \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Showing variable affecting wet granulation method} }
\label{tw-a745120c0d89}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.33\linewidth-2\tabcolsep}p{\dimexpr.3217\linewidth-2\tabcolsep}p{\dimexpr.3483\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Process variable & \cAlignHack Product variable & \cAlignHack Apparatus variable\\
\tblmidrule 
\cAlignHack Impeller chopper rotation speed  &
  \cAlignHack Amount of liquid binder  &
  \cAlignHack Shape \& size of mixing chamber \\
\cAlignHack Load of the mixer  &
  \cAlignHack Characteristic of liquid binder a) Surface tension  \mbox{}\protect\newline b) Viscosity  &
  \cAlignHack Shape \& size of impeller \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Different capacity Blender equipment of Tip Speed Calculation} }
\label{tw-09a3f4c08c47}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{LLLLL}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Different Capacity & \multicolumn{3}{p{\dimexpr(\mcWidth{2}+\mcWidth{3}+\mcWidth{4})}}{\cAlignHack Research \& Development} & \cAlignHack Production \\
\rowcolor{kwdboxcolor}\cAlignHack  & \cAlignHack 2 liters (Gansons) & \cAlignHack 10 liters (Gansons) & \cAlignHack 10 Liters (Sainath) & \cAlignHack 50 liters (Gansons)\\
\tblmidrule 
\cAlignHack Impeller Slow (RPM)  &
  \cAlignHack 85.0  &
  \cAlignHack 36.0  &
  \cAlignHack 207.0  &
  \cAlignHack 155 \\
\cAlignHack Impeller Fast (RPM)  &
  \cAlignHack 170.0  &
  \cAlignHack 72.0  &
  \cAlignHack 415.0  &
  \cAlignHack 310 \\
\cAlignHack Diameter (m)  &
  \cAlignHack 0.56  &
  \cAlignHack 1.32  &
  \cAlignHack 0.355  &
  \cAlignHack 0.43 \\
\cAlignHack PI  &
  \cAlignHack 3.14  &
  \cAlignHack 3.14  &
  \cAlignHack 3.14.0  &
  \cAlignHack 3.14 \\
\multicolumn{5}{p{\dimexpr(\mcWidth{1}+\mcWidth{2}+\mcWidth{3}+\mcWidth{4}+\mcWidth{5})}}{\cAlignHack Tip speed (m/s) }\\
\cAlignHack Impeller Slow  &
  \cAlignHack 2.49  &
  \cAlignHack 2.49  &
  \cAlignHack 3.85  &
  \cAlignHack 3.50 \\
\cAlignHack Impeller Fast  &
  \cAlignHack 4.98  &
  \cAlignHack 4.97  &
  \cAlignHack 7.71  &
  \cAlignHack 7.01 \\
\multicolumn{5}{p{\dimexpr(\mcWidth{1}+\mcWidth{2}+\mcWidth{3}+\mcWidth{4}+\mcWidth{5})}}{\cAlignHack Froude Number }\\
\cAlignHack Impeller Slow  &
  \cAlignHack 0.11  &
  \cAlignHack 0.05  &
  \cAlignHack 0.43  &
  \cAlignHack 0.29 \\
\cAlignHack Impeller Fast  &
  \cAlignHack 0.46  &
  \cAlignHack 0.19  &
  \cAlignHack 1.73  &
  \cAlignHack 1.18 \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Comparison of parameters for Blending between 450 L blender and 4000 L Blender in terms of tangential velocity} }
\label{tw-17514dd19bf3}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1961\linewidth-2\tabcolsep}p{\dimexpr.2479\linewidth-2\tabcolsep}p{\dimexpr.1774\linewidth-2\tabcolsep}p{\dimexpr.3785999999999999\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack S.No & \cAlignHack Parameter & \cAlignHack 450L & \cAlignHack 4000L \\
\tblmidrule 
\cAlignHack 1  &
  \cAlignHack Diameter (m)  &
  \cAlignHack 1.603  &
  \cAlignHack 2.670 \\
\cAlignHack 2  &
  \cAlignHack Radius (m) (r)  &
  \cAlignHack 0.802  &
  \cAlignHack 1.335 \\
\cAlignHack 3  &
  \cAlignHack Blender rpm (N)  &
  \cAlignHack 9  &
  \cAlignHack = 2*\ensuremath{\pi }*r*N (m/min)  \mbox{}\protect\newline =2*3.14*1.335 = 8.384  \mbox{}\protect\newline  = 45.33/8.384 = 5.41 \\
\cAlignHack 4  &
  \cAlignHack =2*3.14*1.335 = 8.384  &
  \cAlignHack 45.33  &
  \cAlignHack Actual : 45.36 (considering 5.41 rpm) \\
\multicolumn{2}{p{\dimexpr(.444\linewidth-2\tabcolsep)}}{\cAlignHack Calculation } &
  \cAlignHack 2*3.14*0.802*9= 45.33  &
  \cAlignHack Actual : 2*3.14*1.335*5.41= 45.36 \\
\cAlignHack 5  &
  \cAlignHack Total revolutions for lubrication  &
  \cAlignHack 45  &
  \cAlignHack 45 \\
\cAlignHack 6  &
  \cAlignHack Total time for lubrication (min)  &
  \cAlignHack 5 min  &
  \cAlignHack 9 min \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {The commercial batches is prepared successfully and sent for market Compiled Date for Technology Dozier} }
\label{tw-aaea9836a42f}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.2812\linewidth-2\tabcolsep}p{\dimexpr.1868\linewidth-2\tabcolsep}p{\dimexpr.1768\linewidth-2\tabcolsep}p{\dimexpr.17509999999999998\linewidth-2\tabcolsep}p{\dimexpr.1801\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Parameters  & \cAlignHack R\&D Trials  \mbox{}\protect\newline Batches  & \cAlignHack Scale up  \mbox{}\protect\newline Batches & \cAlignHack Exhibit  \mbox{}\protect\newline Batches & \cAlignHack Commercial  \mbox{}\protect\newline Batches\\
\tblmidrule 
Batches size (Maximum)  &
  \cAlignHack 2500 Tablets  &
  \cAlignHack 1,50,000  \mbox{}\protect\newline Tablets  &
  \cAlignHack 11,25,000  \mbox{}\protect\newline Tablets  &
  \cAlignHack 50,00,000  \mbox{}\protect\newline Tablets \\
Dispensing weight (Maximum)  &
  \cAlignHack 820mg  &
  \cAlignHack 12.3kg  &
  \cAlignHack 92.25kg  &
  \cAlignHack 410.0mg \\
Sifting sieve  &
  \cAlignHack 40mm  &
  \cAlignHack 40mm  &
  \cAlignHack 40mm  &
  \cAlignHack 40mm \\
RMG Capacity  &
  \cAlignHack 2 litre  &
  \cAlignHack 200 litre  &
  \cAlignHack 750 litre  &
  \cAlignHack 2000 litre \\
Mixing time for RMG  &
  \cAlignHack 5 minutes  &
  \cAlignHack 6 minutes  &
  \cAlignHack 5 minutes  &
  \cAlignHack 8 minutes \\
RMG rpm  &
  \cAlignHack 30 rpm  &
  \cAlignHack 40 rpm  &
  \cAlignHack 60 rpm  &
  \cAlignHack 130 rpm \\
Milling hole size  &
  \cAlignHack 8.0rpm  &
  \cAlignHack 8.0rpm  &
  \cAlignHack 8.0rpm  &
  \cAlignHack 8.0rpm \\
Fluid bed dryer  &
  \cAlignHack 5kg  &
  \cAlignHack 150kg  &
  \cAlignHack 200kg  &
  \cAlignHack 500kg \\
Drying Time  &
  \cAlignHack 45 minutes  &
  \cAlignHack 58 minutes  &
  \cAlignHack 62 minutes  &
  \cAlignHack 85 minutes \\
Drying Temperature  &
  \cAlignHack 50 \ensuremath{\pm} 5 \ensuremath{^{0}} C  &
  \cAlignHack 50 \ensuremath{\pm} 5 \ensuremath{^{0}} C  &
  \cAlignHack 50 \ensuremath{\pm} 5 \ensuremath{^{0}} C  &
  \cAlignHack 50 \ensuremath{\pm} 5 \ensuremath{^{0}} C \\
Drying LOD  &
  \cAlignHack 1.08\%  &
  \cAlignHack 1.33\%  &
  \cAlignHack 1.40\%  &
  \cAlignHack 1.58\% \\
Dry Milling Size  &
  \cAlignHack 1.5mm  &
  \cAlignHack 1.5mm  &
  \cAlignHack 1.5mm  &
  \cAlignHack 1.5mm \\
Milling rpm  &
  \cAlignHack 600rpm  &
  \cAlignHack 500-600rpm  &
  \cAlignHack 600-800rpm  &
  \cAlignHack 800-1000rpm \\
Blender Capacity  &
  \cAlignHack 2 litre  &
  \cAlignHack 400 litre  &
  \cAlignHack 800 litre  &
  \cAlignHack 1500 litre \\
Blender rpm  &
  \cAlignHack 12 rpm  &
  \cAlignHack 12 rpm  &
  \cAlignHack 12 rpm  &
  \cAlignHack 12 rpm \\
Pre Lubrication time  &
  \cAlignHack 10 minutes  &
  \cAlignHack 10 minutes  &
  \cAlignHack 10 minutes  &
  \cAlignHack 10 minutes \\
Lubrication time  &
  \cAlignHack 5 minutes  &
  \cAlignHack 5 minutes  &
  \cAlignHack 5 minutes  &
  \cAlignHack 5 minutes \\
Tooling  &
  \cAlignHack D-Tooling  &
  \cAlignHack D-Tooling  &
  \cAlignHack D-Tooling  &
  \cAlignHack D-Tooling \\
Rotary  &
  \cAlignHack Single  &
  \cAlignHack Single  &
  \cAlignHack Double  &
  \cAlignHack Double \\
Tablets punching machine station  &
  \cAlignHack 8 Station  &
  \cAlignHack 27 Station  &
  \cAlignHack 27 Station  &
  \cAlignHack 55 Station \\
Compression  &
  \cAlignHack 20 rpm  &
  \cAlignHack 27 rpm  &
  \cAlignHack 27 rpm  &
  \cAlignHack 45 rpm \\
Shape  &
  \cAlignHack Capsule Shape Deep Bevel Concave  &
  \cAlignHack Capsule Shape Deep Bevel Concave  &
  \cAlignHack Capsule Shape Deep Bevel Concave  &
  \cAlignHack Capsule Shape Deep Bevel Concave \\
Individual tablets weight  &
  \cAlignHack 820mg  &
  \cAlignHack 822mg  &
  \cAlignHack 821mg  &
  \cAlignHack 825mg \\
Thickness  &
  \cAlignHack 6.00mm  &
  \cAlignHack 6.10mm  &
  \cAlignHack 5.70mm  &
  \cAlignHack 6.10mm \\
Hardness  &
  \cAlignHack 15-17kp  &
  \cAlignHack 15-16kp  &
  \cAlignHack 16-17kp  &
  \cAlignHack 18-19kp \\
DT  &
  \cAlignHack 1min 5sec  &
  \cAlignHack 1min 15sec  &
  \cAlignHack 1min 10sec  &
  \cAlignHack 1min 20sec \\
Coating machine name  &
  \cAlignHack Neocota  &
  \cAlignHack Neocota  &
  \cAlignHack Neocota  &
  \cAlignHack Neocota \\
Pan capacity  &
  \cAlignHack 12 inches  &
  \cAlignHack 36 inches  &
  \cAlignHack 36 inches  &
  \cAlignHack 48 inches \\
Pan speed  &
  \cAlignHack 2-6rpm  &
  \cAlignHack 2-5rpm  &
  \cAlignHack 2-4rpm  &
  \cAlignHack 1-3rpm \\
No.of spray guns  &
  \cAlignHack 1 gun  &
  \cAlignHack 1 gun  &
  \cAlignHack 1 gun  &
  \cAlignHack 1 gun \\
Spray rate  &
  \cAlignHack 3-5rpm  &
  \cAlignHack 3-5rpm  &
  \cAlignHack 3-5rpm  &
  \cAlignHack 3-5rpm \\
Inlet temperature  &
  \cAlignHack 50 {\textendash} 60 \ensuremath{^{0}} C  &
  \cAlignHack 55 {\textendash} 62 \ensuremath{^{0}} C  &
  \cAlignHack 52 {\textendash} 58 \ensuremath{^{0 }}C  &
  \cAlignHack 55 {\textendash} 60 \ensuremath{^{0}} C \\
Bed temperature  &
  \cAlignHack 40 {\textendash} 42 \ensuremath{^{0}} C  &
  \cAlignHack 35 {\textendash} 40 \ensuremath{^{0}} C  &
  \cAlignHack 35 {\textendash} 40 \ensuremath{^{0}} C  &
  \cAlignHack 36 {\textendash} 41 \ensuremath{^{0}} C \\
Individual tablets weight  &
  \cAlignHack 832mg  &
  \cAlignHack 835mg  &
  \cAlignHack 830mg  &
  \cAlignHack 833mg \\
Thickness  &
  \cAlignHack 6.25mm  &
  \cAlignHack 6.26mm  &
  \cAlignHack 6.22mm  &
  \cAlignHack 6.28mm \\
Hardness  &
  \cAlignHack 22-23kp  &
  \cAlignHack 22-23kp  &
  \cAlignHack 22-23kp  &
  \cAlignHack 22-23kp \\
DT  &
  \cAlignHack 2 min 20 sec  &
  \cAlignHack 2min 10sec  &
  \cAlignHack 2min 30sec  &
  \cAlignHack 2min 45 sec \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\bgroup
\fixFloatSize{images/86dbbd52-0fb9-49bd-a180-49416c8f558a-upicture1.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/86dbbd52-0fb9-49bd-a180-49416c8f558a-upicture1.png}{\includegraphics[width=.84\linewidth]{images/86dbbd52-0fb9-49bd-a180-49416c8f558a-upicture1.png}}{}
\makeatother 
\caption{\boldmath {Various stages for Mycophenolate Mofetil Tablets USP 500mg}}
\label{f-35c58305e1c2}
\end{figure}
\egroup

\bgroup
\fixFloatSize{images/0bd29082-28ce-4486-a22c-e8592322e502-upicture2.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/0bd29082-28ce-4486-a22c-e8592322e502-upicture2.png}{\includegraphics{images/0bd29082-28ce-4486-a22c-e8592322e502-upicture2.png}}{}
\makeatother 
\caption{\boldmath {Mycophenolate Mofetil Synthesis}}
\label{f-ce4d23006446}
\end{figure*}
\egroup
\textbf{Granulation}

Add binder solution of over a period of 2 minute while mixing with impeller at slow speed and chopper off. Based on granulation consistency add additional quality of purified water over a period of 1 minute with impeller at slow speed and chopper off.  Knead the wet mass over a period of 1 minute with impeller and chopper at fast speed. Discharge the wet mass at impeller slow speed through co-mill with 12.0mm screen into fluid bed dryer bowl.

\textbf{Drying}

Drying the wet mass of an inlet temperature of 50\ensuremath{^{0}}C \ensuremath{\pm} 5\ensuremath{^{0}}C in fluid bed dryer till to get LOD in the range of 1.0 to 2.0\% w/w at 80\ensuremath{^{0}}C by auto mode using suitable moisture analyzer.

\textbf{Milling }

Mill the dried granules by using suitable mill, fitted with 1.5mm screen at medium speed /knives forward direction until all the granules are passed through the screen.

\textbf{Extra-Granular Material Sifting}

Microcrystalline cellulose (Avicel PH 101) \& Croscarmellose sodium (Ac-di-sol) together through mesh \# 40Sift magnesium stearate through mesh \# 60

\textbf{Pre Lubrication}

Microcrystalline cellulose (Avicel PH 101) \& Croscarmellose sodium (Ac-di-sol) into suitable blender and blend for 10 minutes at 12 rpm.

\textbf{Lubrication}

Magnesium stearate Lubricated blend for 5 minutes at 12 rpm.

\textbf{Compression}

\textbf{Tooling Details}

17.80 \ensuremath{\times} 8.90mm capsule shape deep bevel concave punches embossed with `H' on lower punch and ``MRV'' on upper punch.

\textbf{Coating (Film Coating Suspension)}

Take weighed quantity of water filled in a container equipped with a propeller stirrer. Add Opadry II complete film coating system 85F200021 Purple slowly to the purified water while stirring. Increase the speed of stirrer if necessary continue stirring for 45 minutes or till a smooth homogeneous suspension is obtained. Transfer core tablets into coating pan tablets bed temperature reaches approximately 40 \ensuremath{\pm} 5\ensuremath{^{o}}C. The weight gain of the tablets as per the standard operating procedure. Stop the coating when the average tablets gain is 2.5 \ensuremath{\pm} 0.5\% w/w of core tablets weight \unskip~\cite{1120148:22369906}.

\textbf{Tip Speed Calculation}

The constant Impeller Tip Speed means same shear rate in both the RMGs which \unskip~\cite{1120148:22369907}  is an alternative to constant power in relative swept volume [Tables~\ref{tw-a745120c0d89} and~\ref{tw-09a3f4c08c47}].
\begin{eqnarray*}\style{font-family:'Times New Roman'}{\style{font-size:8px}{Tip\;Speed\;=\;\pi\times N\times D/t}} \end{eqnarray*}
where, N = RPM of the impeller; D = Diameter of the impeller, t = Kneading or Mixing time


  
  \begin{enumerate}
  \item \relax Blender sweep Diameter (m) of 150L: 1.136 m
  \item \relax Blender sweep Diameter (m) of 300L: 1.449 m
  \item \relax Blender sweep Diameter (m) of 450L: 1.603 m
  \item \relax Blender sweep Diameter (m) of 1200L: 2.043 m
  \item \relax Blender sweep Diameter (m) of 4000L: 2.670m
  \end{enumerate}
  Based on above calculation, 9 rpm in 450L blender is almost equivalent to 5 rpm in 4000L blender maintaining the Tangential velocity constant. So for 4000L blender the equivalent Lubrication time is 9minutes at 5 rpm for Mycophenolate Mofetil USP tablets 500mg. Comparison of parameters for Blending between 300L blender and 4000L Blender in terms of tangential velocity [Table~\ref{tw-17514dd19bf3}].


\bgroup
\fixFloatSize{images/06eb293f-fd36-4338-96ac-8f32f4afe93c-upicture3.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/06eb293f-fd36-4338-96ac-8f32f4afe93c-upicture3.png}{\includegraphics[width=\linewidth]{images/06eb293f-fd36-4338-96ac-8f32f4afe93c-upicture3.png}}{}
\makeatother 
\caption{\boldmath {Structure of Mycophenolate Mofetil USP}}
\label{f-ee1025675581}
\end{figure}
\egroup
\textbf{Blender}

These industrial blenders are sturdily constructed in precise dimension and offer high performance without any hassle. Keeping ourselves abreast of cutting edge technology \unskip~\cite{1120148:22369906}. They find application for the purpose of mixing and lubricating the granules homogeneously.

\textbf{Reasons for Blend Testing}

To optimize the blend time during development phase. To demonstrate lack of segregation in bins/drums during material handling to confirm that specified blend conditions produce acceptable uniformity during validation. Blend assays can be used to release finished product. The type of blending like Double cone blender, Octagonal blender, Ribbon blender, Coata blender, V-blender \unskip~\cite{1120148:22369906,1120148:22369915}.

\textbf{R} \textbf{\&D Trials Batches}

The batch size of lab scale batches is 820mg or 2500 Tablets. The shape of Mycophenolate Mofetil Tablets is round and get individual average weight of tablets is 820mg of lab batches (500mg API +320mg Excipients) for the preparation of granules stated with dispensed so the 500gm raw material dispensed including excipient and sift by 40mm (\#40) sieve and wet granulation method for using RMG Capacity 10 litre and mixing speed 5 minutes \unskip~\cite{1120148:22369910}. Wet milling 8.0mm and drying for 45 minutes at 50\ensuremath{^{o}}C \ensuremath{\pm} 5\ensuremath{^{o}}C in fluid bed dryer till to get LOD in the range of 1.08\% w/w at 80\ensuremath{^{o}}C and Extra granular into two part one is pre lubrication 10 minutes and lubrication 5 minutes for 12 rpm The mixed by octagonal blenders mixer. After mixer the product and compresses the tablets by 20rpm speed at 8 stations. The compressed tablets moved for next step i.e evaluation of tablets parameters. The weight of randomly selected tablets 820.000 \ensuremath{\pm} 5\% (Maximum Acceptable 779.000 to 861.000) The Hardness of randomly selected tablets 17.5kp (Maximum Acceptable 10.0 to 20.0kp) measured by using (Kraemer Hardness) tester and next Friability measured by Electrolab Type Friabilitor Measured rotate by 100rpm. The result of Friability loss than is NMT 1.0\% the tablets taken form Disintegration is 45-50sec (Maximum Acceptable NMT 10min). The Thickness of tablets is 6.00 \ensuremath{\pm} 0.30\% (Maximum Acceptable 5.70 - 6.30mm) measured by Digital Vernier Caliper. The Film coated of tablets the about parameters of spray rate 2-4 rpm pan capacity 36 inches Inlet temperature about 50 to 60\ensuremath{^{o}}C bed temperature about 40 to 42\ensuremath{^{o}}C The weight of randomly selected tablets 832.000 \ensuremath{\pm} 5\%. The Hardness of randomly selected tablets 19.2kp measured by using (Kraemer Hardness) tester and next Friability measured by Electrolab Type Friabilitor Measured rorate by 100rpm. The tablets taken form Disintegration is 2min 30sec (Maximum Acceptable NMT 10min). The Thickness of tablets is 6.26mm measured by Digital Vernier Caliper as shown in Table~\ref{tw-aaea9836a42f}.\textbf{\space }

\textbf{The R\&D Trials batches is Acceptable \& Successful within limit further go for scale up batches}

The batch size of lab scale batches is 12.3kg or 150000 Tablets. The shape of Mycophenolate Mofetil Tablets is round and get individual average weight of tablets is 820mg of lab batches (500mg API + 320mg Excipients) for the preparation of granules stated with dispensed so the 500gm raw material dispensed including excipient and sift by 40mm (\#40) sieve and wet granulation method for using RMG Capacity 100 litre and mixing speed 6 minutes. The Wet milling 8.0mm and drying for 58 minutes at 50\ensuremath{^{o}}C \ensuremath{\pm} 5\ensuremath{^{o}}C in fluid bed dryer till to get LOD in the range of 1.33\% w/w at 80\ensuremath{^{o}}C and Extra granular into two part one is pre lubrication10 minutes and lubrication 5 minutes for 12 rpm The mixed by octagonal blenders mixer. After mixer the product and compresses the tablets by 36rpm speed at 27 Stations. The compressed tablets moved for next step i.e evaluation of tablets parameters. The weight of randomly selected tablets 820.000 \ensuremath{\pm} 5\% (Maximum Acceptable 779.000 to 861.000) The Hardness of randomly selected tablets 17.5kp (Maximum Acceptable 10.0 to 20.0kp) measured by using (Kraemer Hardness) tester and next Friability measured by Electrolab Type Friabilitor Measured rorate by 100rpm. The result of Friability loss than is NMT 1.0\% the tablets taken form Disintegration is 45-50sec (Maximum Acceptable NMT 10min). The Thickness of tablets is 6.00 \ensuremath{\pm} 0.30\% (Maximum Acceptable 5.70 -6.30mm) measured by Digital Vernier Caliper. The Film coated of tablets the about parameters of spray rate 2-4 rpm pan capacity 36 inches Inlet temperature about 50 to 60\ensuremath{^{o}}C bed temperature about 40 to 42\ensuremath{^{0}}C The weight of randomly selected tablets 832.000 \ensuremath{\pm} 5\%. The Hardness of randomly selected tablets 19.2kp measured by using (Kraemer Hardness) tester and next Friability measured by Electrolab Type Friabilitor Measured rorate by 100rpm \unskip~\cite{1120148:22369916}. The tablets taken form Disintegration is 2min 30sec (Maximum Acceptable NMT 10min). The Thickness of tablets is 6.26mm measured by Digital Vernier Caliper as shown in Table~\ref{tw-aaea9836a42f}.

\textbf{The Scale up batches is Acceptable \& Successful with in limit further go for Exhibit batches}

The batch size of lab scale batches 82.00kg or 11,00,000 Tablets. The shape of Mycophenolate Mofetil Tablets is round and get individual average weight of tablets is 820mg of lab batches (500mg API + 320mg Excipients) for the preparation of granules stated with dispensed so the 500gm raw material dispensed including excipient and sift by 40mm (\#40) sieve. And wet granulation method for using RMG Capacity 750 litre and mixing speed 5 minutes. Wet milling 8.0mm and drying for 62 minutes at 50\ensuremath{^{o}}C \ensuremath{\pm} 5\ensuremath{^{o}}C in fluid bed dryer till to get LOD in the range of 1.40\% w/w at 80\ensuremath{^{0}}C and Extra granular into two part one is pre lubrication 10 minutes and lubrication 5 minutes for 12 rpm The mixed by octagonal blenders mixer. After mixer the product and compresses the tablets by 20rpm speed at 8 stations. The compressed tablets moved for next step i.e evaluation of tablets parameters. The weight of randomly selected tablets 820.000 \ensuremath{\pm} 5\% (Maximum Acceptable 779.000 to 861.000). The Hardness of randomly selected tablets 17.5kp (Maximum Acceptable 10.0 to 20.0kp) measured by using (Kraemer Hardness) tester and next Friability measured by Electrolab Type Friabilitor Measured rorate by 100rpm. The result of Friability loss than is NMT 1.0\% the tablets taken form Disintegration is 45-50sec (Maximum Acceptable NMT 10min).The Thickness of tablets is 6.00 \ensuremath{\pm} 0.30\% (Maximum Acceptable 5.70 - 6.30mm) measured by Digital Vernier Caliper. The Film coated of tablets the about parameters of spray rate 2-4 rpm pan capacity 36 inches Inlet temperature about 50 to 60\ensuremath{^{o}}C bed temperature about 40 to 42\ensuremath{^{o}}C The weight of randomly selected tablets 832.000 \ensuremath{\pm} 5\%. The Hardness of randomly selected tablets 19.2kp measured by using (Kraemer Hardness) tester and next Friability measured by Electrolab Type Friabilitor Measured rorate by 100rpm. The tablets taken form Disintegration is 2min 30sec (Maximum Acceptable NMT 10min) \unskip~\cite{1120148:22369918}. The Thickness of tablets is 6.26mm measured by Digital Vernier Caliper as shown in Table~\ref{tw-aaea9836a42f}.

\textbf{The Exhibit Commercial batches is prepared Successful and sent for regulatory authority for market approval}

The batch size of lab scale batches 820.00Kg or 10,00,000 Tablets. The shape of Mycophenolate Mofetil Tablets is round and get individual average weight of tablets is 820mg of lab batches (500mg API + 320mg Excipients) for the preparation of granules stated with dispensed so the 500gm raw material dispensed including excipient and sift by 40mm (\#40) sieve. And wet granulation method for using RMG Capacity 2000 litre and mixing speed 5 minutes. Wet milling 8.0mm and drying for 85 minutes at 50\ensuremath{^{o}}C \ensuremath{\pm} 5\ensuremath{^{o}}C in fluid bed dryer till to get LOD in the range of 1.58\% w/w at 80\ensuremath{^{0}}C and Extra granular into two part one is pre lubrication 10 minutes and lubrication 5 minutes for 12 rpm The mixed by octagonal blenders mixer. After mixer the product and compresses the tablets by 20rpm speed at 8 stations. The compressed tablets moved for next step i.e evaluation of tablets parameters. The weight of randomly selected tablets 820.000 \ensuremath{\pm} 5\% (Maximum Acceptable 779.000 to 861.000) The Hardness of randomly selected tablets 17.5kp (Maximum Acceptable 10.0 to 20.0 Kp) measured by using (Kraemer Hardness) tester and next Friability measured by Electrolab Type Friabilitor Measured rorate by 100rpm. The result of Friability loss than is NMT 1.0\% the tablets taken form Disintegration is 45-50 Sec (Maximum Acceptable NMT 10min). The Thickness of tablets is 6.00 \ensuremath{\pm} 0.30\% (Maximum Acceptable 5.70 - 6.30mm) measured by Digital Vernier Caliper. The Film coated of tablets the about parameters of spray rate 2-4 rpm pan capacity 36 inches Inlet temperature about 50 to 60\ensuremath{^{o}}C bed temperature about 40 to 42\ensuremath{^{o}}C The weight of randomly selected tablets 832.000 \ensuremath{\pm} 5\%. The Hardness of randomly selected tablets 19.2kp measured by using (Kraemer Hardness) tester and next Friability measured by Electrolab Type Friabilitor Measured rorate by 100rpm. The tablets taken form Disintegration is 2min 30sec (Maximum Acceptable NMT 10min). The Thickness of tablets is 6.26mm measured by Digital Vernier Caliper as shown in Table~\ref{tw-aaea9836a42f}.
    
\section{RESULT \& DISCUSSION}
\textbf{Scale up batches}

The batch size of lab scale batches is many required post approval changes that affected in the formulation site and manufacturing process or equipment 12.3kg or 1,50,000 Tablets small scale up batch with different capacity of equipments, tip speed calculation data and analytical report find the from the regulatory standpoint, scale up and scale-down are treated with the same degree of scrutiny The Scale-up batches is Acceptable \& Successful with in limit further go for Exhibit batches.

\textbf{Exhibit batches}

This technique has some limitation which are these techniques useful for commercial batch maximum batch size for 1500kg batch that affected in the formulation site and manufacturing process or equipment 82.00kg or 11, 00,000 Tablets the Exhibit batches is prepared Successful and sent for regulatory authority for market approval.

\textbf{Commercial batches}

The Novel Validation batch is run successfully and collects all the increased amount of tablet from techniques useful for commercial batch maximum batch size for 1500kg batch that affected in the formulation site and manufacturing process or equipment 410.0kg or 50,00,000 Tablets the commercial batches is prepared Successful and sent for regulatory authority for market approval. The commercial batches is prepared successfully and sent for market.
    
\section{CONCLUSION}
The aim of this research work is about the various a novel observer critical parameter \& techniques a scale up batches \& Exhibit batches to reduce the time and with limit. Transformation of these Small-Scale observation of different in quality (Tip speed calculation RMG Occupancy blender calculation, compression machine and Neocota machine various techniques) A comparison between fixed and variable speed operations has been made to show the performance of the proposed different machine capacity, Time the scale up batches Exhibit batches so our target is time saving and techniques problem.
    
\section{ACKNOWLEDGEMENT}
I would like to thank Dr. Shalini Geneshan, Assistant professor, Department of Bioinformatics, The tips global Institute affiliated to Bharathiar University, Coimbatore -641046, Tamil Nadu, India.

\textbf{F}\textbf{undin} \textbf{g Support}

No financial support for the current study

\textbf{Conflict of Interest}

The authors attest that they have no conflict of interest in this study.
    

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