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Quality Control

Advertising through visual and print medias stating the quality image like “our foods are made only from high quality ingredients”’ is often a very subtle way. Eye catch packaging has always been treacherous . In order to improve and control the quality of the dietary supplement is to understand the meaning of the term quality. “Quality is not achieving agreed customer expectations or specifications”. It is not to put the product under Quality Control system to ensure that the product meets this criteria.

Controlling quality can be easily achieved through the following:

1. Inspection of raw materials to ensure that no poor quality ingredients are used.

2. Imposing check barriers on the processing like weight, temperature control and time of heating.

3. Microbiological and Heavy Metal Testing of the finished product.

However there are many unsaid/unnoticed parameters where shortcomings in the Quality Control can occur.

For example:

Problem

  • Many times unsaid particles like animal hair, iron metals get embedded down the herbs.
  • Bad flavour and the non-responsiveness of the dietary supplement.
  • Processed Dietary supplement carries Microbes / bacteria / Heavy metals

Reason

  • The system involves drying the raw herbs in the sun on the mat where on many occasions cats and dogs can be seen asleep on a nice warm bed of herbs.
  • Due to poor storage herbs are subject to infestation by insects and rodents.
  • The herbs have been stored next to cleaning material in the storage area or the companies have no documented rules or the storage and handling of cleaning material.
  • Contaminated water.
  • Proper heating temperature maintenance.

However, satveda follows a wider approach than quality control known as “TOTAL QUALITY ASSURANCE”. Total Quality Assurance takes a much wider view of what is involved in satisfying consumer’s needs. It rather focuses on the prevention of the problems and not only their remedy. Remedifying a problem is expensive and quality cannot be “inspected into” a product. Right from the supplier of the raw material through - cleaning and inspection,  analysis of raw material, processing of the dietary supplement, internal business management, analysis of the finished product, packaging and finally to the customer makes what satveda calls as Total Quality Assurance . The quality assurance system of satveda is well documented at each step in a very simple and concise manner to know who owes and what . For doing what ,when and how the focus of quality assurance for satveda is prevention which means that action is taken to meet a specification and put a stop of failures for occurring a second time. All this at satveda comes as an outcome of planning, management, agreements with suppliers and the people involved in production and distribution.

It is the responsibility of satveda to ensure that the quality assurance parameters together with the equipment and information are available to our workers to allow them to exercise their control. Our workers are well aware that they can resolve most of the quality problems within their control.

The process flow chart for herbs we follow at our plant  is as given below:

Herbs in general contain very high levels of micro-organisms and are also subject to contamination with foreign matter . Main reason for this contamination is during harvest processing of herbs which is restricted to low temp. during cleaning and grinding.

Quality Assurance in Raw Material Supply:

A good product cannot be made from second rate raw material. The greatest gains in finished product quality is to focus on pre-purchase areas. The 1st step is to know the supply chain from grower to purchaser and then identifying all potential hazards and their severity. The next step is to eliminate or minimise these hazards.

 

Our Quality Assurance System in the selection of Raw herbs:

  • Team of 2 persons – A doctor (MD Ayurveda and a Pharmacist in Ayurveda are responsible for purchase.
  • We carry out regular visits to the growers also.
  • Team of satveda is responsible for arranging collection of harvested material so that the time between the harvest and the processing is reduced to have a better quality product.
  • satveda team discourages on-farm washing and drying. satveda prefers washing and drying at their own plant .
  • While we buy from bigger agents, we inspect supplier’s stores to check the cleanliness and to find if there exists any sign of insect or rodent infestation.

Our visits to our raw herbs suppliers’ warehouse.

Quality Assurance and Control in the satveda Processing Plant:

Although all stages in a process are vital, errors in the early stages build up, becoming larger problems later, which cannot usually be corrected. Therefore careful attention to the initial stages of a process are beneficial in maintaining quality.

 

Steps involved in the stocking of the Raw Herbs:

  1. A sample is taken from the centre of the gunny sacks in order to ensure that the whole bag is of optimum quality.
  2. Appearance and presence of contaminants
 

(a)     A big sample of the incoming raw hers is spread on a white muslin cloth to examine the infestation of moulds, foreign matter, rodent hairs, broken seeds etc.

 

(b)     Insome cases where seeds are used like Mucuna seeds we place a small sample in the water to find whether they have been attacked internally by insects as the attacked

 

 

(c)     Seeds will float on water. Sometimes the animals also start floating on the water. In such cases satveda rejects the material and does not at all use that raw material for processing.

 

(d)     In some materials the size of pieces evaluates the quality of raw material. satveda performs this size test by weighing a known number of the product and find the efficacy of the raw material.

 

(e)     satveda has a separate area for performing Filth Test. Sample of the raw herb is mixed with petrol and left for a while and when the particles settle down, the insect parts are seen floating on the surface of the petrol.

Odour and flavour: We have experienced PO (app. 20 yrs who has spent his whole life in the herbs) who everytime visits, checks the aroma that needs to be natural and not synthesised essential oil. A proper check on the tastes of the herbs is also analysed as per API.

Moisture Content: The grower wants to sell the herbs with maximum H20 content without realising the impact of moisture on the final product as dietary supplement. Too high moisture content leads to moulds and yeasts. We at satveda India take the sample of the raw herbs & calculate the moisture content to meet API standards.

Quality Assurance in Processing of Herbs:

 

Stages involved are:

satveda is committed for Quality Assurance and hence we try to purchase Raw Herbs from Govt. certified body which assures us of clean raw herbs . HHA Consortium installs big machines that use electrically  operated  winnowers with variable speed fans and adjustable baffles that separate stones, chaff and dust . An electric powered machine picks up the good quality average weighed seeds so that there exists uniformity in the raw material .

 

 Manual Cleaning : Though we get high quality raw herbs from our raw herb suppliers - a govt body , still we clean the herbs at our end so that the Quality Assurance is maintained .Cleaning of leafy herbs has to be done manually and any unsound material or foreign matter is done manually at our premises .

 

Washing: In the case of herbs it is most important to wash them as soon as they arrive in order to remove 'field heat' and thus slow down the growth of micro-organisms. Large amounts of  purified water is  used . After washing with purified  water, De-mineralised water is used for washing the pre-washed herbs .We do not use any chemicals for washing  . Washing is done in large shallow tanks with continuous  running water  so that the herbs move freely in the water to wash - off soil and any other foreign matter.

 

Drying : There is obviously a high risk of contamination  if the raw materials are laid out in the sun. Even the  fan driven dryers may suck in fine dust particles in dusty areas . In order to avoid  airborne dust contaminants , HF uses steel mesh wire baskets covered with muslin cloth under the green-house  , so that the natural process of drying  is attained keeping the natural colour of the raw herb intact and not allowing the passage of air-borne contaminants  during the drying of  pre- clean and pre-washed herb .Two persons keep on unfurling the herbs so that the drying time is minimised to get better microbial quality of the herb.

Storage of the Clean , Washed and Dried Herb :

After drying, the material ,it is packed quickly into clean heavy-gauge plastic sacks to avoid any moisture pick-up. Our staff does not directly handle the herbs , but use scoops and clean gloves. Sacks are labelled and dated and samples are taken for moisture testing.

Dried products are stored under proper conditions, off the floor on wooden pallets that are covered with plastic sheets  and away from walls so that the store-room is easily  kept clean. Herbs may lose their bright colour if exposed to sunlight and over-wrapping with big black plastic sheets is done . The store is regularly inspected and cleaned for which a Clean-In-Place is regularly done . A documentation for the same is maintained which can be checked by anyone.

 

Quality Assurance In Grinding :

Grinding is normally done using either pulverizers or multi mill or small grinders . All our grinders are made up of 316 Steel grade as per USFDA  and WHO standards . The A-grade dried herbs are pulverized at an optimum frequency suitable to retain its active properties . Ground herbs are passed through a fine sieve to give a product with a uniform particle size. Finely ground herbs absorb water much more quickly than whole form  and it is quickly packed into airtight containers. The left coarse powder is

thereafter potentiated using in-house developed Bhavana-decoction of the same complete herb (Traditional ayurvedic system to fortify the herb). Then that decoction is added to the same herbs' pulverized powder  and thereafter micro-pulverised in the ball mill to make them free flowing.

 

Note: Bhavana-decoction method is based on Traditional Ayurvedic principle "Mardanam Gunvardhnam" means "Trituration increases the efficacy to many folds".

Grinding may give rise to a considerable amount of fine dust which attracts insects. To curb this situation we have  housed  grinding mills in a separate room that can be thoroughly cleaned at the end of the day. A vacuum cleaner is used for cleaning up fine dust as brushing tends to push dust into the air for it to settle elsewhere on the machinery . Fine powder  dust may be an irritant to workers and protective masks and goggles are provided to our workers . At this stage we collect two sample sizes send them to a govt certified laboratory for complete analysis of the finished product . Here our finished product undergoes physical ,chemical, biological , microbiological and heavy metal testing.  Also on the other side the recieved fine powder  is sent for either  encapsulating  or we pack it in the bulk form small packages .

Encapsulation : Vegetarian capsules are cellulose based capsule shells that are used to encapsulate the material. Vegetarian capsules are made from a substance called HPMC, which stands for hydroxypropyl methylcellulose (often shortened to hypromellose). This contains no animal matter (unlike gelatin capsules) and is suitable for all.

One of the benefits of having capsules is that capsules have a consistent disintegration time, typically less than 30 minutes i.e. the capsule shell takes about 30 minutes to disintegrate once it has been eaten. Another benefit of taking capsules is that the capsule shell offers excellent protection for oxygen sensitive ingredients so capsulated supplements will stay fresher longer.

 

Packaging and Storage of finished products : Selection of packaging requires much thought and attention as it represents the final defence for the product in the chain of processing  to the customer. The inner bags , outer silver bags , the bottles and the lids are all food grade quality and we use only USFDA certified packaging material.

Each of our bags can be  recycled and reused, which can be an environment friendly .

QC for Pakaging Material

Our suppliers of packaging material critically analyze their  products with latest testing technology and systems to ensure USFDA standards . They conduct several tests as per USP 661 and 671.

  • Physicochemical Test
  • Heavy Metal
  • Buffering capacity
  • Non-Volatile Residue
  • Residue on ignition
  • Thermal Analysis (DSC Test)
  • Light Transmission by UV – VIS Spectrophotometer (Shimadzu)
  • Material Identification by FT – IR (Perkin Elmer)
  • WVTR Test
  • MVTR Test
  • ESCR Test
  • They maintain a clean room environment with complete epoxy flooring and walls and HEPA Filter of 0.3 microns in production zone. Also, they employ a unique raw material central conveying system which feeds raw material directly to fully automatic machines which produce desired product without any human contact. We have a controlled temperature warehousing system with proper segregation in terms of grades to assure zero degradation in quality and no mix ups at any level.
  • Good staff are important in quality assurance: Our team includes Ayurvedic MD Doctors, Pharmacists in Ayurveda , Chemists and of course the workers. It is important to recognise that any system is operated by people. It is people who manufacture a food product and ensure that it has the right quality. People working together ensure that the information, materials and equipment are all correct to allow the production of a product. All therefore need the necessary training and skills to complete their tasks correctly. They need to know what their own responsibilities are in this quality chain and where they fit into the overall system .During the processing the attention of workers and manager is focused on the prevention of problems rather than cures. Though quality and safey glove their hands together still they are different aspects and we classify them individually. Safety is not an option but it is an essential part of the planning, preparation and production of our products. Any lack of consideration of safety can result in a grave consequence - satveda is aware of.  satveda believes that as a manufacturer, it has the responsibility to provide consumers with safe, wholesome products, continuous awareness programs are designed specifically for our workers. satveda does this with the belief that quality assurance can only be operated when the production staffs are well informed, educated, well trained and motivated. Our Hazard Analysis Critical Control Point (HACCP) system is based on quality control, microbiology, Heavy metal and risk management. To ensure we work in the following manner:

Physical

wood, string, dirt, etc.

Biological

bone, hair, insects, faeces

Chemical

Pesticides , chemicals in water

Microbiological

yeasts, moulds; bacteria, viruses

Heavy Metal

Mercury ,Lead , Cadmium, Arsenic

Control Procedures At Control Points

Building design

The type of building in which dietary supplements are manufactured and the general level of plant hygiene have a major influence on product quality. Our Plant at INDIA - satveda INDIA has been specifically built for Dietary Supplements. The site of the plant is on a cleared ground, away from sources of insects, rodents, or smells. It has clean fresh air as it is constructed in the middle of lush green fields .These fields trap the airborne dust. A road access for ingress and exit of products leads to our plant premises. We have separate DRY AREA for moisture free work and WET AREA for water based or drying processes as both leave lot of moisture .HF also have dug up their own deep bored water wells. A regular power supply is present.

Externally and internally the plant is smooth plastered and painted with water-resistant paint.  Around the sinks the walls are tiled. Windows are fitted with fly-proof mesh nets. The gaps between the doors and the floors have been sealed with bristle traps .Power chords are internally fitted thereby leaving no chance for spiders, rat, insects, birds and rodent traps. Drains are fitted with a removable fine mesh. 3- Phase supply exists in our plant.

Excellent ventilation with large mesh covered windows, roof vents, ceiling fans, exhaust fans, Air Humidifiers has been provided. 

Washing and toilet facilities have been separated building by two closed doors between the toilet and the processing area to prevent insects and odours from entering.

 
Water quality is essential to quality assurance and dietary supplements processing requires a good supply of clean, potable water for cleaning equipment, cooling filled containers and sometimes as a food ingredient. For this, HF has installed water purifying plant. The two wells dug up supply the water to the Water Tank1, which sends water to the water purifying plant. Here we get RO water and then De- mineralised water. From the de-mineralised water steam plant acts and converts the de-mineralised water into steam water. This steam water gets collected in water tank 2 which is used for every internal processing of the dietary supplements- from washing of the herb to the internal cleaning of the premises.

Sanitation and hygiene

Buildings and equipment

The building and equipment must be kept clean at all times as part of a planned quality assurance programme. A thorough clean-down at the end of the day is essential but this alone is not sufficient. Workers at our plant are trained to keep equipment clean throughout the day and to remove waste as they accumulate. The most important point is that the manager identifies all areas then develops a cleaning plan. Most importantly, the manager allows adequate time for cleaning down.

For wet processes, cleaning involves the use of hot water only.

A regular C-I-P is done and documented every 15 days.

Hygiene of the workers

Operators are a potential source of contamination for which hygiene procedures are established in the factory. Such measures include the following:

  1. 1. All workers use clean uniforms, shoes and caps that cover the hair.
  2. 2. All workers first wash their hands and feet with soap and then sanitise with herbal sanitise at the start of each production session. Electric hand dryer is used to dry the hands.
  3. 3. Sanitizers and sinks have been fitted at the entry port of processing area so that after using the toilet worker does not enter without washing and sanitising the hands and feet. Smoking and spitting is banned from the processing rooms.
  4. 4. Wearing of  jewellery or foreign objects is not allowed.
  5. 5. A separate dining hall has been built to take eatables or food far away from the processing room.
  6. 6. Change areas have been constructed inside the building to change clothing before entering the processing room.
  7. 7. Workers who are ill, and especially if suffering from cough or skin infections are not under any circumstances, allowed to handle the products.
  8. 8. Workers with infected cuts, boils or abrasions on their hands are removed from the production area and put to other works like cleaning, painting and repairs if any.

We have an extensive system for maintaining the highest possible standards for quality control of our herbs. Your health and well-being is our only priority. We employ leading experts in the field of Ayurveda, and we have partnered with reputable laboratories in India HERBAL HEALTH AYURVEDIC CONSORTIUM- A GOVT. BODY to ensure the purity and safety of our herbs.

Testing for botanicals is generally classified into the following four categories: Microbiological, Heavy Metals, Pesticides, and Identification.

Microbiologicals

satveda requires microbiological testing and certificates of analysis from all of our suppliers for every batch of herbs. Testing is done not only at our suppliers end but bearing the onus we make sure that before providing you with these dietary supplements we analyze at our end also and we feel happy in measuring your safety at our end. All of our herbs and formulations are tested in one of the north India’s' biggest laboratory. The herbs are tested for the following:

Total Aerobic Microbial Count
Total combined yeast and molds
Coliforms
E. Coli
Salmonella

Our labs use USP methods 2021 and 2022 as specified by the Ayurvedic Pharmacopoeia of India, which are in conformity with the standards specified by the USFDA and WHO and AYUSH. They are as follows:

Total aerobic microbial count 10^7
Total combined yeast and molds 10^5
Coliform 10^4
E. Coli absent in 1 gm
Salmonella absent in 10 gm

Certificates of Analysis (C of A) with test results are available on request for all of our herbs.

Heavy Metals

We test our herbs and products for arsenic, cadmium, lead and mercury using the services of Herbal Health Ayurvedic Consortium - Laboratory. All of our products are within the safety guidelines as per USFDA and API .The acceptable limits for daily intake are as follows:

Arsenic content shall not exceed 0.01 milligrams per daily dose (10 micrograms per day)
Cadmium content shall not exceed 0.006 mg/d (6 micrograms per day)
Lead content shall not exceed 0.02 mg/d (20 micrograms per day)
Mercury content shall not exceed 0.02 mg/d (20 micrograms per day)

Pesticides

The focus of satveda is on being a supplier of i-house-manufactured herbs. For an herb to be pesticide free we make sure that regular visits to the growers is paid and we try to educate them regarding the same from time to time .

Identification

This involves the physical examination of the herbs using the senses of sight, taste, smell and touch. Our staff includes recognized experts in the field of Ayurvedic herb identification. In addition, qualified botanists in India conduct botanical verification of every species grown and also identify the species at the collection point. We use visual identification, microscopic identification (involving checking plant cell structures against pharmacopoeia standards) as well as Thin Layer Chromatography (TLC) and High Performance Layer Chromatography (HPLC) to verify that what we are collecting is actually the correct species. Only on passing these tests do the plants proceed for further cleaning and drying.

Once dry, the herbs are subjected to tests in accordance with the Ayurvedic Pharmacopoeia of India. This reveals that the levels of solids, ash content and active ingredients present in the plants actually conform to the recommended reference ranges.

 Commitment to Excellence

All of our procedures here at satveda are in alignment with industry standards and in accordance with the US FDA’s cGMPs (current Good Manufacturing Practices).

We are continually making improvements to our facility, systems and procedures. Every change we make is structured and characterized to be fully compliant with the USDA’s National Organic Program and the cGMPs for Dietary Supplements. We firmly believe that Quality Assurance is a regulao process and we keep abreast with the same.