Unlike other industries, aroma chemical industry requires additional care and quality systems to take care of the odor. Actually we can visualize this industry as selling the smell rather than the products. To meet this requirement, the following quality systems and procedures ensure overall quality assurance from the receipt stage to dispatch stage.
A]. Receipt stage:
All the in coming Raw materials and packaging materials should be stored in a spacious storage area with clear demarcations for Approved materials and rejected materials.
Every lot Raw material and packaging material should be checked thoroughly as per approved specifications, even minor deviations should be noted and investigated.
Packaging material should be inspected from odor point of view.
All the approved lots should be labeled with Green colored “APPROVED”labels and rejected ones with Red colored “REJECTED” labels to have better visual control.
B]. Manufacturing stage:
All processes should have well documented and authorized standard operating procedures.
The log sheet of each process should reveal the traceability of the materials used in the process.
There should be well validated and documented cleaning procedures with schedules to avoid the cross contaminations.
Every container used for the storing the materials in the Manufacturing area should bear the proper labels to eliminate the cross contaminations and mix-ups.
C]. Blending stage:
This is very crucial stage of controlling the quality; different fractions should be stored separately with proper labels indicating the purity and odor status.
Make small blends of 1kg (Called preblend) and test for the odor and analytical parameters, if found ok, then the final bulk blend to be done in the same proportion as that of preblend.
Storage tanks should be equipped with nitrogen purging and proper aeration facilities to remove off odors.
D]. Laboratory controls:
Infra structure: Quality control department should have the following infra structure.
1]. Analytical Instrumentation lab
2]. Wet analysis lab
3]. Olfactory analysis chambers
4]. Control samples Room
5]. Market sample preparation Room
6]. Documentation room
The laboratory should be well equipped with modern instruments to monitor different physical and chemical parameters to ensure the product meeting the global standards. Below mentioned instruments are required.
1] Tintometer: To measure the color of the liquid materials
2] Refractometer: To measure the Refractive index, very important parameter
3] Densitometer: To measure the density
4] Autotitrator: To determine the Acid value and Assay
5] Karlfisher: To determine the moisture content
6] Polarimeter:To determine the optical rotation
7] GLC: To determine the impurities and purity
8] GLC/GCMS with Head space: To determine the volatile impurities like solvents in PPM level
9] AAS: To determine the metallic impurities like iron, lead, mercury etc
10] Boiling and melting point apparatus: To determine the MP/BP
11] Stability chamber: To derive the packing material compatibility and storage conditions
E]. Odor analysis:
There should be olfactory panel of minimum 3 members to evaluate the odor of the different fractions so as to make correct final blend. The panel members should be subjected to periodic tests to monitor their odor analysis capabilities. The olfactory analysis chamber should be clean and neat, and be kept under positive pressure to prevent the out side odors from entering and members should be odor free in the sense they should not use any perfumes, aftershave lotions or perfumed hair oils etc. Olfactory analysis should be carried out starting from light odors to strong odors. Odor analysis should be recorded for top note, middle note and end note.
Panel members should refresh themselves by smelling coffee beans whenever they feel exhausted. Used smelling strips should be disposed into the container containing the water to prevent the spread of the odors.
F]. Documentation: Good documentation system should be in place as per the following list.
Quality Assurance:
1]. RM/PM specifications
2]. In process material specifications
3]. Finished product specifications
4]. Test procedures
5]. Customer specifications
6]. Deviation reports
7]. Analytical instruments calibration record
8]. Control sample record
9]. Test reports
10]. Material physical inspection records
11]. Olfactory analysis record
12]. Vendor audit reports
G]. Production:
1]. Manufacturing procedures
2]. Cleaning procedures for production equipments
3]. Calibration record of equipments
4]. Logsheets of Production batches
5]. Corrective actions record of deviations
6]. Analysis reports of in process samples
7]. Records of blending activities
G]. Packing:
When it comes to packing, only new packing materials free from odors should be used at any cost. Used drums should not be employed.
Packing material compatibility should be tested before finalizing the packing material. Compatibility should be tested for the following parameters after storing the material for minimum one month.
1]. Odor and taste
2]. Purity
3]. Color
4]. Clarity
5]. PH
6]. Acid value
7]. Heavy metals
8]. Leakages
New packing material vendors should also be evaluated based on above parameters
H]. Ware housing:
This is the crucial and critical facility required to maintain the quality till the shelf life. The facility should be spacious enough (depending upon the no of products and production capacities) to keep the different lots of QC cleared products separately by maintaining minimum 1 mt distance for easy access. The drums/carboys should be kept on the wooden/plastic pallets. There should not be any leakage of water from the roof. The temperature with in the ware house should be maintained 25 – 30 deg C, since the aroma chemicals develop color and acidity when exposed to higher temperatures. The material older than six months should be retested to ensure the quality.
I]. Quality systems:
In addition to above internally monitoring quality systems, the following externally certified in quality, safety, environmental and social affairs are essential to become globally recognized aroma chemical 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]
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