How Important is Equipment Validation in the Pharma Industry?
Disasters often stir humankind into constructive action. It was in the wake of the infamous “Contergan Scandal” that Good Manufacturing Practice (GMP) evolved in the United States in 1963 . And, the issue of sterility in the parenteral market made two Food and Drug Administration (FDA) officials put forth the concept of validation in 1979 .
Pharma products have a direct impact on the health of the consumers. Ensuing quality of products is, therefore, a top priority for regulators. Dosage strongly impacts the percentage of the drug that reaches the site of action. Therefore, each batch of manufactured drugs must be of the same quality , meaning consistency is of paramount importance.
Equipment Validation documents evidence that a piece of equipment conforms with the required standards across all stages . GMP ensures that quality is an integral part of a product and not merely tested in it . Equipment validation is a component of GMP which guarantees that the equipment maintains the required standards and, as a result, consistently provides products of the necessary quality .
Cybernetik has successfully validated and delivered multiple pieces of equipment for the pharmaceutical industry. Our technicians engage with clients throughout the equipment validation process, while conforming with the US FDA Part 211 and Part 11, EU Annexe 11, and cGMP standards, and also drafting the necessary documents.
When the validated equipment is part of a larger process, the validation documents play another key, although indirect, role – that of rapid error detection. If the process output is not as expected, technicians need to pin point the error. They can safely rule out equipment defect because it is already validated .
Equipment Validation for Pharma Industry Equipment
Cybernetik implements validation for pharmaceutical equipment through the following distinct steps which include the documents mentioned therein:
Client URS (User Requirement Specification): is the starting point of the validation process and describes what performance the client expects out of the equipment . Customers can either provide the client URS directly or our personnel create it after capturing their requirements.
Internal URS: converts client URS into a set of instructions and particulars for our technicians.
Design & Development: defines the various components of the equipment, their capacities, materials, location in the overall set up, and other relevant features. Two documents/phases are particularly important:
Functional Design Specifications (FDS): describes how the system will perform its expected operation. FDS is the source for functional design requirements.
Detailed Design Specifications (DDS): is the source for the detailed design requirements and explains how to build the system. FDS and DDS are normally verified during qualification or commissioning.
Design Qualification (DQ): ensures that the end user’s point of view is incorporated in the design process.
Factory Acceptance Testing (FAT): analyses whether the equipment performance conforms with the end user’s specifications. The venue for FAT is the Cybernetik shop floor. After a successful FAT, the customer and Cybernetik clear the machine for dispatch after certifying that it has been built to satisfy the User requirements (as per URS) and in accordance with FDA and DQ.
Installation Qualification (IQ): ensures that the client’s facility provides the appropriate setting for the piece of equipment . IQ is based on DQ . The three most common verifications during IQ are whether the equipment has adequate space allotted in the facility, is connected to the necessary utilities, and is installed with the required software . Technicians also check if the equipment installation:
Integrates it with other equipment/systems .
Complies with qualification protocol and plan .
Considers all the equipments sub parts .
Makes arrangements for maintenance, calibration, and cleaning in future.
Utilizes the relevant national/international standards for calibration, measurement, and control.
Notes all equipment details such as model, serial number, spares, installation date, certificates.
Operational Qualification (OQ): is based on IQ. Technicians check if the:
Equipment operates as expected, particularly at the extreme operational ends  and follows the required operational sequence .
All equipment components operate correctly.
Technicians are correctly trained to operate the equipment.
Standard Operating Procedures (SOPs) are finalized and ratified.
All results are documented.
Performance Qualification (PQ): examines if the equipment/system performs consistently under load as required by the design specifications. Technicians create all the necessary documents for performance verification.
For building quality into pharma products, there is also a need to build unwavering precision into the equipment validation process. Because we cannot afford to forget that drugs are a lifeline for many!
Cybernetik has successfully validated pharmaceutical equipment for a diverse set of clients. Engaging with clients right from the design qualification stage, we walk them smoothly through the installation, operational, and performance qualification stages.
High Pressure Equipment Designs for Food Processing Applications, Food Engineering Series.
Industrial Pressure Kettle VKP, FoodTechProcess.
Food Storage, Preparation and Safety: In-depth, Croner-i.
Chocolate Making: A Delicious Business
Chocolate is among the most popular non-essential food items globally . An essential ingredient of several delicacies such as candy bars, milk shakes, cookies, and cereals , it makes a particularly important component for puddings, cakes, brownies, and other desserts .
Before it gets to the dining table, the chocolate has literally travelled around the world. The journey of chocolate begins on the evergreen cocoa trees located in the equatorial and tropical regions of South America, Mexico, Africa, and Southeast Asia.
After manually harvesting cocoa beans, workers ferment and dry them. Fermentation turns them brown and drying reduces their weight to half . Next, cocoa beans are shipped to manufacturing facilities where they are roasted, winnowed, ground, and blended to form the chocolate we are familiar with .
Manufacturers first clean the beans to remove unwanted material. Next, they roast and winnow the beans to obtain the edible part called “nib,” which is the edible part of the bean.
Thereafter, they melt the nib, and add sugar and flavor to it. The liquid chocolate so produced is either stored or molded into the required solid form .
Let us examine each stage of the manufacturing process in detail:
Roasting: is the important first step and plays several important roles:
Brings out the taste and flavor because it is the roasted cocoa beans that taste like chocolate, not the raw ones . Typical cocoa bean color and aroma develop around 130-1500C .
Sterilizes the bean, eliminating any bacteria, molds, and fungi that are widespread in the tropical equatorial regions – the home of cocoa beans .
Simplifies cracking and winnowing by disconnecting the inner bean from the outer husk . Roasting makes the outer cocoa shells brittle, making it easy to separate them . Breaking down the inner cocoa bean gives tiny cocoa nibs .
Reduces moisture content from around 7% to about 1% . This is important because chocolate and water do not mix. Lowering moisture simplifies grinding . For effective roasting, three conditions are essential viz. transfer of heat to the bean, smooth airflow in the roasting drum, and cooling .
Winnowing: involves delinking the husk (outer shell) from the nib (edible part) of cocoa beans. The process directly impacts the final quality of the chocolate as better separation delivers top quality . Any residual husk will introduce unwanted tastes . Winnowing takes off 20-25% of the roasted beans’ weight . Equipment for winnowing cracks open the outer husks, which are then segregated from the nib by multiple stages of sieves (filters). Air blowing fans complete the separation as husks are lighter than nibs . Roasted beans are cracked open by passing them through serrated cones  or screw motion . Vibration mechanisms may also be employed in addition to filters and fans for superior separation .
Grinding: passes nibs through rotating metal drums to convert them into liquid called chocolate liquor . Nibs contain 50-55% cocoa butter , which is a crucial ingredient for making chocolate. Depending on the requirements, manufacturers utilize three or even more grinding stages . The roller speed rises in every successive stage . Eventually, the size of chocolate liquor particles is crushed to 0.0254mm . From the middle of the grinding stage, the process handles liquid chocolate and this continues till step 8 i.e. molding stage.
Separation: involves the use of hydraulic press  or rollers  to hike the pressure on chocolate liquor. This makes most of the cocoa butter inside the chocolate liquor flow out as a yellow liquid. The residue is the press cake and is processed into cocoa powder .
Blending: manufacturers add cocoa butter to the press cake . The quantity of added cocoa butter influences the consistency and texture, and, therefore, determines the type of chocolate produced .
Conching: is the most critical stage in chocolate production . Operating somewhat similar to eggbeater, the machine paddles move to and fro through the chocolate mass slowly to mix it thoroughly and aerate it . Such action further reduces the chocolate particles’ size and removes any minor, residual bitterness. Process speed and temperature influence the quality of chocolate . Other determinants of quality are the speed at which other ingredients (sugar, milk powder or milk, cocoa butter, flavors etc.) are mixed and when they are added .
Tempering: is the slow cooling of the conched chocolate. Such machines can have heating and cooling mechanisms as well as mixers to maintain the molten chocolate’s homogeneity . Steady temperature drop in tempering imparts stability to the chocolate  i.e. prevents the ingredients from separating on solidification – when poured in molds for example . It also maintains the chocolate’s crisp texture and luster . It is the tempering stage that prevents chocolate from melting when people touch it .
Molding: is the pouring of liquid chocolate into molds designed to provide the specifically shaped chocolate. Types of chocolates are pure chocolates, wafer or cookie including chocolates, raisin or dry fruit containing chocolates, or those with a core containing different materials such as jelly . Totally automatic, semi automatic, and manual are the three types of mold machines based on the level of automation . Stage 8 i.e. molding starts with liquid chocolate and ends with a solid one. Hereafter, all stages deal with solid chocolate.
Wrapping: protects the chocolate from contamination while also lending it a catchy appearance and enabling the makers to brand their produce. After loading the wrapper material and chocolate (of the required size and shape) in the wrapper machine, the machine wraps the chocolate, cuts the wrapper, and seals it. Thereafter, the wrapped chocolates are packaged into cartons . Types of wrapper machines are Bar Wrapper, Coin Wrapper, Foil Wrapper, and Fold Wrapper. Different ways a chocolate is wrapped are Banding, Fold Wrapping, Foil Wrapping, Pleat Wrapping, Sleeve Wrapping, Twist Wrapping, and Foil and Band Wrapping . Chocolates can be wrapped as much as five times viz. primary, double primary, secondary, tertiary, and final wrappings . Molding machine is an auxiliary to the wrapping machine . Equipment that serve as auxiliaries to both machines are :
Auto Chocolate Depositor
A process as long and complex as chocolate making demands diligent focus from the involved people and machines. Automation is a great way to make the process precise and fast.
Cybernetik has delivered customized automation and equipment solutions for the chocolate industry that enable close monitoring and control over each stage to make exceptional quality chocolate.
The production of chocolate, Simon Fraser University.
Cocoa Bean Roasting, Chocolate Alchemy.
Cultivation, Preparation & Roasting the Cocoa beans, Ritter Sport.
An Introduction To Cocoa Roasting, XTC Chocolate.
Cocoa Roasting Machine, Coffee Direct Pro.
Cocoa Bean Winnowing, Oklahoma State University.
Making Exceptional Chocolate: Winnowing Cocoa Beans, Wild Mountain Chocolate.
How To Make Chocolate: From Cacao Bean to Chocolate, The Gourmet Chocolate of the Month Club.
The Nib-grinding Process, The Manufacturing Confectioner.
Tempering Chocolate, Ghirardelli.
Chocolate Moulding Machine, SaintyCo.
Chocolate Wrapping Machine, SaintyTech.
A New Normal
Global crises trigger far reaching and fundamental transformations in consumer preferences, industrial practices, and government policies. The COVID-19 pandemic is no different. It will force manufacturers to comprehend those aspects of business, society, and politics that will be radically modified. Furthermore, they will have to proactively build capacity to deal with the new normal .
Following areas will experience paradigm shifts:
Automation: will be increasingly deployed to resurrect the manufacturing sector. Productivity expansion via robotics and automation will be at the focal point of this effort, which will generate fresh employment opportunities for digitally proficient workers, but not for the low-skilled ones .
Rapid Factory Digitalization: that places a premium on flexible and precise management of factory operations from a remote location. Such management will necessitate fast incorporation of industrial IoT based on superior data visualization, sensing, artificial intelligence, and tools for remote collaboration .
Digital Divide among Manufacturers: two broad sets of manufacturers will emerge in the wake of the socio-economic decline. At the top end will be the digitally-savvy ones who embarked on the digital journey years ago. The late entrants will be at the other end .
Greater Attention to Health & Safety: Good Manufacturing Practice (GMP) and Current GMP (cGMP) will assume more significance given their focus on plant and operator hygiene. Employees can expect greater monitoring and tracking of their movements and geographical data viz. residence location, recent travels and particularly international travel . Industries will also rearrange workspaces, operate in staggered shifts, maintain more distance between employees, and prohibit visitors on the shop floor to prevent coronavirus transmissions .
Improved Strategies for Worker Retention & Deployment: particularly for workers who have to be on-site. Such workers will receive more education on how to respond to symptoms and contain the spread of the virus .
Flexible Management Practices: that incorporate change management and adaptable work schedules to effectively handle greater automation levels, more number of remote employees, and the learning curves of such employees .
“Virtual Shift” Replacing “Physical Shift”: with fewer people on the shop floor (on site), a team of virtually-connected experts will be continuously available online for consultation by the shop floor personnel. Facilitating the virtual shift will be AI-enabled tools, real time handling of data, and numerous collaboration cum communication instruments . The virtual shift will digitally scale the expertise of the specialist team over the entire institution while boosting the productivity of the shop floor team .
Emphasizing Cybersecurity & System Capacity to Resist Attacks: with more employees gaining online access to the main system areas, security of cyber network will be of paramount importance. The system design has to be resilient in order to withstand repetitive attacks .
Supply Chain Overhaul: is necessary in order to avoid last minute unavailability of parts, particularly the critical elements. Manufacturers will take more efforts to thoroughly understand in real time their supply networks. Suppliers identified as vulnerable to disrupting the chain will be replaced .
Survival of the Adaptable
Adaptability will be the key to survival at a time when the COVID-19 pandemic has unleashed rapid and extensive transformation in most aspects of the manufacturing sector. The challenge also presents a huge opportunity for the digitally savvy manufacturer.
Cybernetik delivers customized automation solutions for a whole range of manufacturing operations.