Unlike other industries, the aroma chemical industry requires additional care and quality systems to take care of the smell. Actually, we can visualize this industry selling the smell instead of the products. To meet this requirement, the following quality systems and procedures ensure overall quality assurance from the receiving stage to the shipping stage.
HAS]. Stage receipt:
All incoming raw materials and packaging materials must be stored in a spacious storage area with clear demarcations for approved materials and rejected materials.
Every batch of raw material and packaging material must be thoroughly checked against approved specifications, even minor deviations noted and investigated.
Packaging material should be inspected for odor.
All approved lots should be labeled with green “APPROVED” labels and all rejected lots with red “REJECTED” labels for better visual control.
B]. Manufacturing stage:
All processes must have well-documented and authorized standard operating procedures.
The record sheet for each process must reveal the traceability of the materials used in the process.
There should be well validated and documented cleaning procedures with schedules to avoid cross contamination.
All containers used for the storage of materials in the Manufacturing area must have the appropriate labels to eliminate cross-contamination and confusion.
VS]. Mixing stage:
This is a very crucial stage of quality control; the different fractions must be stored separately with adequate labels indicating the state of purity and smell.
Make small 1kg mixes (called premixes) and test for odor and analytical parameters, if found ok then the final bulk mix will be made in the same ratio as the premix.
Storage tanks must be equipped with nitrogen purging and adequate aeration to remove odors.
D]. Laboratory controls:
Infrastructure: The quality control department must have the following infrastructure.
1]. Analytical Instrumentation Laboratory
two]. Wet analysis laboratory
3]. Olfactory analysis chambers
4]. control sample room
5]. Market sample preparation room
6]. documentation room
The laboratory must be well equipped with modern instruments to monitor different physical and chemical parameters to ensure that the product meets global standards. The instruments mentioned below are required.
1]Tintometer: To measure the color of liquid materials
2]Refractometer: To measure the refractive index, a very important parameter
3]Densitometer: To measure the density
4]Automatic titrator: to determine the acid number and assay
5]Karlfisher: To determine the moisture content
6]Polarimeter: To determine the optical rotation
7]GLC: To determine impurities and purity
8]GLC/GCMS with Head space: To determine volatile impurities such as solvents at the PPM level
9]AAS: to determine metallic impurities such as iron, lead, mercury, etc.
10]Melting and Boiling Point Apparatus: To determine MP/BP
11]Stability chamber: to derive compatibility of packing material and storage conditions
me]. Odor analysis:
There must be an olfactory panel of at least 3 members to evaluate the smell of the different fractions in order to make a correct final mixture. Panel members must undergo periodic testing to monitor their odor analysis capabilities. The olfactory analysis chamber must be clean and tidy and kept under positive pressure to prevent external odors from entering and members must be odor free in the sense that they must not use perfumes, aftershaves or scented oils to the hair etc. The olfactory analysis must be carried out from light odors to strong odours. The odor analysis must be recorded for the top grade, the middle grade and the final grade.
Panel members should refresh themselves by smelling the coffee beans whenever they feel exhausted. Used scent strips should be disposed of in the container containing the water to prevent the spread of odours.
F]. Documentation: There must be a good documentation system according to the following list.
Quality assurance:
1]. MR/PM Specifications
two]. In-process material specifications
3]. Finished Product Specifications
4]. Test Procedures
5]. customer specifications
6]. Deviation reports
7]. Analytical instrument calibration record
8]. Control sample registration
9]. test reports
10]. Material physical inspection records
eleven]. Olfactory analysis record
12]. Supplier audit reports
GRAM]. Production:
1]. manufacturing procedures
two]. Cleaning procedures for production equipment.
3]. Equipment calibration record
4]. Production batch record sheets
5]. Corrective actions recording of deviations
6]. In-process sample analysis reports
7]. Merge activity logs
GRAM]. Packaging:
As far as packaging is concerned, only new, odour-free packaging materials should be used at all costs. Used drums should not be used.
The compatibility of the packaging material must be tested before finalizing the packaging material. Compatibility should be tested for the following parameters after the material has been stored for a minimum of one month.
1]. smell and taste
two]. Purity
3]. Color
4]. Clarity
5]. pH
6]. Acidity index
7]. Heavy metal
8]. leaks
New packaging material suppliers should also be evaluated based on the above parameters.
H]. Storage:
This is the crucial and critical facility required to maintain quality through shelf life. The facility must be spacious enough (according to the number of products and production capacities) to keep the different batches of quality control approved products separately maintaining a minimum distance of 1 meter to facilitate access. Drums/carboys must be stored on wooden/plastic pallets. There should be no water leaking from the roof. The temperature inside the warehouse should be kept between 25 and 30 degrees C, as aromatic chemicals develop color and acidity when exposed to higher temperatures. Material older than six months must be retested to ensure quality.
ME]. Quality systems:
In addition to the above internal monitoring quality systems, the following external certifications in quality, safety, environmental and social issues are essential to becoming a globally recognized aroma chemicals organization.
1]ISO-9000-[Quality management system]
2]ISO-14000[Environment management system],
3]OSHAS-18000-[Occupational safety and health administration system ]
4]ISO-22000 and HACCP-[Food safety management system]
5]GMP-[Good manufacturing practices as per FDA]
6]REACH Registration – [For export to EUROPE]
7]SA-8000- [Social accountability system]
