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STANDARD OPERATING PROCEDURES FOR SACHET WATER FACTORIES

STANDARD OPERATING PROCEDURES FOR SACHET WATER FACTORIES

One of the required documents to be submitted during the NAFDAC registration process for manufacturers is the “Standard Operating Procedures (SOP)” for key operations. The required standard operating procedures for sachet water factories includes, the SOP for production, SOP for quality assurance, SOP for equipment maintenance, SOP for equipment and factory cleaning and sanitation, SOP for cloaking and use of toilet, SOP for distribution, consumer complaints and recall… and even SOP for the purchase of equipment, accessories, and production materials! Um, abeg, the last one is not part of NAFDAC requirements, technically…

So it is not too hard to imagine what goes through the minds of regular entrepreneurs bold enough to venture into the sachet water production and packaging business, as they tick off the items on the list of required documents to be submitted to NAFDAC. CAC certificate – yes, very clear. Trademark, simple. Food handlers test certificate, fumigation certificate, laboratory reports, retainership agreements, and other sundry documents, all ticked off as simple, with an accompanying understanding nod of the head. And then you remember glossing through a series of SOP’s – Standard Operating Procedures in the list, and reappraise the few items with SOP attached to them as part of the requirements.

Well, the experienced business folks understand what it entails and know how to go about it. However, for the regular first-timers, it is understandable if some assume it is something to be gotten from the Standards Organization of Nigeria (SON). While a few others who are internet- compliant, waste little time before searching online for answers.

The standard operating procedures for sachet water factories are easy to write for those with a little experience. They can draft out something reasonable, off-heart, or with an already written sample as guide. But for the inexperienced production manager and business owner, it calls for a little pencil-butt chewing.  Okay, for the sake of those potential factory owners that do not like big-big English, wetin be standard operating procedure sef

For a list of equipment and accessories to set up a water production and packaging factory [LISTS]

WHAT ARE STANDARD OPERATING PROCEDURES (SOP’s)?

An SOP is basically an outline of required steps for the completion of a specific process. English!

To be candid, the internet is filled with better and easy to understand explanations, so abeg, do the needful. A simple analogy would be, a map with detailed directions of getting to a particular destination. Closer home, SOP’s are like a particular recipe for how to cook Egusi soup… Yes, you are right. There are a variety of Egusi soups, and different cooking methods, which explains my point exactly! The list of ingredients, with particular instructions as contained in the particular recipe, help ensure that the final product is Egusi soup, and not some herbal concoction. In the case of sachet water production and packaging factories, NAFDAC is the gourmet whose standards must be met, or exceeded. Abeg, let’s leave Egusi soup alone and continue

 Hence, the required standard operating procedures for sachet water production and packaging factories are the different step-by-step procedures carried out in key operations in the course of producing quality sachet water in accordance with good manufacturing practice (GMP), and in compliance with regulatory standards.

A well written and well implemented SOP not only ensures maintenance of standards, but also fast-track seamless integration of people, process, and product. This has the potential of reducing human errors, and attendant production downtime that may result.

BASIC STANDARD OPERATING PROCEDURES: CLEANING AND SANITATION

Two pdf samples, one basic, and the other comprehensive, of cleaning and sanitation standard operating procedures for sachet water factories are made available for free download and usage. The first SOP for cleaning is a “Basic” SOP integrating cleaning and sanitation procedures for production equipment, accessories, and factory premises. This summarizes the key steps in the cleaning and sanitation processes, written in a format that assumes the production manager or business owner is familiar with the overall steps.

Basic SOP: Cleaning and sanitation [Basic Pg. 1] [Basic Pg. 2].

COMPREHENSIVE STANDARD OPERATING PROCEDURES (SOP): CLEANING AND SANITATION

This comprehensive SOP for cleaning and sanitation in a sachet water factory is written in a loose format with detailed step-by-step instructions for the cleaning of the production room, cleaning of the various production equipment and accessories inside and outside of the production room (e.g. sachet water packaging machine, UV sterilizer, the microfilters, the raw and treated water storage tanks, the sand and carbon media filters, the ozonator, and the surface pumps etc.),  sanitation of the factory exterior, as well as the various sections of factory interior.

It is written specifically for sachet water production and packaging business owners and inexperienced production managers, to serve as a guide for the factory cleaning staff, the production assistants, and machine operators.

[Pg. 1] [Pg. 2] [Pg. 3] [Pg. 4] [Pg. 5] [Pg. 6] [Pg. 7] [Pg. 8]

[Pg. 9] [Pg. 10] [Pg. 11] [Pg. 12] [Pg. 13] [Pg. 14] [Pg. 15]

For those who wouldn’t mind the little effort drafting out the complete standard operating procedures required by NAFDAC, feel free to use any of the samples provided as guide, or edit to use directly. For others who would prefer we draft the SOP’s for them, our telephone number is scattered all over this website, so do not hesitate to contact us to discuss your requirements.

Check out the basic steps to get NAFDAC  number for your water production and packaging factory […] 

 

Basic Equipment and Materials for Bottle or Sachet Water Production in Nigeria

For every one with the intention to start a bottle or sachet water production factory, it is appropriate to know the facilities, equipment, accessories and sundry materials needed for the successful operation of a water production factory.

The factory should comply with NAFDAC regulatory standards as regards sectioning, directional flow of departments, operating procedures and other sundry requirements. The NAFDAC Guidelines for setting up a Packaged Water Factory and Food Manufacturing Factory gives a better outline of the registration process. The basic equipment and materials for bottle or sachet water production in Nigeria are outlined below.

GENERAL SAFETY:

  • Fire Extinguishers
  • Fire Blankets
  • Sand Buckets

RAW WATER PRODUCTION EQUIPMENT:

This is your source of raw water for producing your packaged bottle or sachet water. The submersible pump is meant for factories that use boreholes instead of municipal or other water source. All the pumps must not be made from galvanized metal. Three (3) Storage Tanks are ideal. One tank for Raw Water storage, another for treatment process and the third tank for post-Treatment water Storage.

  • PVC Water Tanks (Black Colour preferably)
  • Submersible Water Pumping Machine (1HP or more)
  • Surface Pumping Machine (1HP or more)
  • Aeration faucets
  • PVC Pipes and plumbing fittings

WATER TREATMENT EQUIPMENT AND REAGENTS:

There are completely automated combo units with RO Filter systems for water treatment, these are more expensive. The fibre filter plant is the next best filter module followed by the regular carbon and sand filter units. Dosing can be manually done, however, dosing pumps make for easy addition of chlorine and other chemicals during the treatment process.

  • Reverse Osmosis (RO) Module
  • Industrial Water Filtration Modules (Fibre Plants, Activated Carbon Bed & Sand Bed Filters)
  • Ozone Generator
  • Micro-Filter Cartridge Housing/Casing
  • Micro-Filter Cartridges (0.5µ (Micron), 2µ and 5µ pore Size)
  • Ultra-Violet (UV) Sterilizer
  • Ultraviolet (UV) Lamps (Switches should be placed outside the rooms!)
  • Dosing Pumps
  • Liquid chlorine
  • Calcium hypochlorite powder
  • Hydrogen peroxide
  • Isopropyl alcohol (IPA)
  • Green sand, activated carbon/charcoal, ion exchange resins (cations & anions)
  • Alkali (NaOH, KOH)
  • Mineral acid (HCl, H2SO4, HNO3)

NOTE: Some of the chemicals listed above are for cleaning the RO membrane, others are for disinfection purpose in water treatment, or factory cleaning and sanitation.

 

 PACKAGED BOTTLE & SACHET WATER PRODUCTION EQUIPMENT:

For Bottle Water production, the machines can be fully automated combo units or semi-automated units. Manual filling methods are not allowed by regulation for conventional plastic bottles sizes except for dispenser bottles.

  • Fully Automated Bottle Water Production Line (Automatic washing, filling & capping combo unit)
  • Semi-Automated Bottle Washing Machine
  • Semi-Automated Bottle Filler
  • Semi-Automated Bottle Capper/Corker
  • Automatic or manual electric Batch coding machine
  • Automatic labeling machine (labeling can be done manually)
  • Shrink wrap machine (shrink wrapping can be done with > 500W electric shrink guns or gas lamps)

Update on the basic equipment and materials for bottle or sachet water production in Nigeria as of the year 2019, NAFDAC requires fully automated bottle water production machine/line for new bottle water factory registration. Already existing bottle water factories with semi-automated machines, have been directed to upgrade their facilities to fully automated bottle water production line. We are not privy to given deadlines for compliance, but refusal to renew the NAFDAC registration number of products for defaulting factories is one possible penalty. Another possibility is outright sealing of defaulting facilities pending full compliance. 

For Sachet Water production, an analogue or digital automatic sachet water filler machine is the standard. The read out screen and knobs is what differentiate analogue sachet water filler machines from digital ones.

  • Automated Sachet Water Filler (Analogue or digital) with batch coding capacity.
  • Batch Coding Stamp (For machines without automatic batch coder)
  • Receiving Basin
  • Short stools/chairs (plastic or stainless steel)

PACKAGING MATERIALS

  • Bottle Mould (for branded bottles)
  • Bottles (50 cl, 60 cl, 75 cl, 1 L, 1.5 L)
  • Bottle Caps (28 mm, 30 mm )
  • Labels
  • polythene shrink wraps (for bottle packaging)
  • Packaging Nylon (printed sachet rolls)
  • Packaging bags (wraps for sachet water pieces)
  • Hot Air Gun ( for fixing labels and cap seals)

PERSONNEL PROTECTIVE EQUIPMENT:

  • Reusable or disposable Food Handling gloves (preferably powder-free polyethylene or latex), as well as heavy duty rubber gloves.
  • Hygiene Face masks
  • Head Net/Cap
  • Laboratory Coat/Apron
  • Rubber Boots/Clogs
  • Hand sanitizers

QUALITY ASSURANCE EQUIPMENT (IN HOUSE):

Large scale facilities have a fully functional laboratory. However, for regular water production facilities, basic in-house quality assurance requires at least physical checking of water products for odour, colour, particles and taste. The measurement meters such as pH meters and conductivity meters are used to check the pH, conductivity,  Total Dissolved Solids and a few other parameters that help indicate the quality of the treated, and produced water. Full Laboratory analyses for the water products are outsourced to IPAN registered laboratories.

  • pH Meter (hand held or bench top)
  • Conductivity/TDS Meter
  • Weighing Balance (from 2kg Load capacity above)
  • Glass Beakers (600ml/1000ml capacity)
  • Glass Measuring Cylinder (500ml capacity)
  • Water Testing Kit
  • Plastic pallets. Technically a QC material with many preventive functions.

CLEANING & SANITATION

  • Bottle Washer Brush
  • Long-Handle Hard Brush (for cleaning the storage tanks)
  • Food Grade Liquid Detergent
  • Cleaning Mop
  • Dust Brush/Sweeping Brush
  • Cobweb Brush
  • Disposable Wipes
  • Waste Bin
  • Pallets (Plastic)

Your Bottle or Sachet water production factory is expected to have a means of effective product distribution, production records and other necessities required for successful operation of your business.

Check out samples of cleaning and sanitation standard operating procedures (SOP) for sachet water production and packaging factories [Cleaning SOP].

BASIC STEPS TO GET NAFDAC NUMBER FOR YOUR FACTORY PRODUCED BOTTLE/SACHET WATER IN NIGERIA

Before you begin setting up a bottle/sachet water production factory here in Nigeria, you should first download the National Agency for Food and Drug Administration and Control (NAFDAC) Guidelines for Establishment of Packaged Water Plant in Nigeria and also, Guidelines for Registration of Food and Water on their website or any other online platform. The basic steps to get NAFDAC number for your factory produced bottle/sachet water in Nigeria, is contained in these guidelines. However, if after going through the guidelines, you are still not clear on any issue, it is best to visit the NAFDAC office nearest to you for better explanation of the guidelines and requirements needed for their approval and subsequent issuing of NAFDAC number for your produced bottle or sachet water.

Based on experience and a few research, below are the summary of a few steps they will advise you to take for a smooth application process.

Step 1:             REGISTER YOUR BUSINESS WITH THE CAC

Get your business registered with the Corporate Affairs Commission (CAC) wherever you are in Nigeria. A Business Name Registration (Enterprise) might do, but Incorporation (Ltd) is ideal. You can register an Enterprise i.e. Business Name online yourself, however, the services of a lawyer, accountant or company secretary registered with the CAC is a must for Incorporation. Your CAC Certificate should be out in a week or two for Enterprises and maximum of sixty (60) days for company Incorporation. This gives your water production factory legal identity.

Step 2:             REGISTER YOUR TRADEMARK

The next of the basic steps to get NAFDAC number for your factory produced bottle/sachet water in Nigeria is the processing of product trademark. With your CAC certificate, you go to the Federal Ministry of Industry, Trade and Investment to get your water product trademarked. The product could be the same as your full company name, similar to the water production factory name or a different name altogether e.g. Space-Tech Scientifique Water or Space-Tech Water or XYZ Water. What is important is that your company gets associated with the registered product trademark.
There are different trademark registration categories for respective products and sectors, hence choose the specific Class Specification of Goods/Services else you will have issues with the NAFDAC registration. Water products come under Class 32. As a result of verification procedures, your trademark certificate takes a bit of time to become ready, but a preliminary notification should be out within two (2) months if the trademark is uncontested.

Step 3:             SETTING UP THE BOTTLE/SACHET WATER FACTORY

Stage A.          PRE-PRODUCTION/ADVISORY INSPECTION

Say, you’ve picked out an ideal location to site your bottle/sachet water production factory and you want to rush everything through structure-wise. Well, before you start building or equipping the acquired space, it is best practice to apply for a Pre-Production/Advisory Inspection by NAFDAC to ascertain if the location meets the requirements for setting up a bottle/sachet water producing factory.

Yes, you’d visited NAFDAC office at the onset, and you’re better informed about the don’ts for site location. An onsite inspection allows NAFDAC inspectors give firsthand evaluation of the acceptability of your site in addition to technical advice about distance of your borehole to the septic tank, the direction flow of section units such as where your Cloak room, Raw Material store etc should be, as well as vital nuggets of other information.
You can skip this step if you know what you are doing but it is advisable you don’t as evidence of Pre-Production Inspection is required for the registration process.

Stage B.          CONSTRUCTION AND EQUIPPING

Once your site is adequate, you can now rush through your building construction or demarcations as the case may be. The direction of flow of respective sections should be Cloakroom, Packaging material store, Raw material store, Production section, Finished products store, making sure there are insect-proof nets on all windows and the doors are self closing. If you are going to produce sachet and bottle water, two distinct sections should be provided for each product. Also remember to label all the equipment and rooms/areas accordingly, as well as provide adequate convenience rooms away from the production section(s) but easily accessible from there.

Where there is unavailability of municipal water, drill your borehole (150ft deep or more), run the plumbing, do a raw water laboratory analyses, install the water treatment plants and water producing equipment, making sure you follow all the regulatory guidelines specified, put the necessary safety equipment in place, test run the various setups and smile as you fix the few glitches that crop up. Still interested in setting up a water production factory?

Step 4:             NAFDAC REGISTRATION

Stage A.          BEFORE APPLICATION FOR PRODUCTION INSPECTION

Your water production factory is fully setup and all you need is for NAFDAC to come certify your production facility and bless you with the almighty NAFDAC number. Well, before you can apply for Production inspection, you’d need to have the following in place:

  1. Production staff, which must include a Production Manager with appropriate science-based qualifications and experience.
  2. Food Handlers Certificate for all your staff (production and non production), which is given by a hospital after general medical check-ups and laboratory tests to ascertain the health status and fitness of each personnel to handle food meant for public consumption.
  3. Evidence of retainership agreement between your factory and a medical facility for health related issues
  4. Evidence of recent fumigation of factory premises from a certified fumigation company as well as a partnership agreement for fumigation purposes between your factory and the company.
  5. Comprehensive laboratory analyses report for your raw water i.e. borehole or municipal water before undergoing treatment and your treated water (after treatment from your installed water treatment plant). This should be done by a qualified Institute of Public Analyst of Nigeria (IPAN) laboratory.
  6. Quality assurance agreement between your factory and an IPAN laboratory for subsequent analyses of batches of produced sachet or bottle water, this is if you do not have an In-house Quality Assurance Department.
  7. Standard Operating Procedures (SOP) for production, Quality Control, in and out-premises sanitation, equipment maintenance, product distribution and recall, hygiene and others, written in appropriate format and signed by the Production Manager.
  8. Company organogram identifying key personnel, their names, designation and qualification.
  9. Letters of Appointment for your key personnel together with their letters of acceptance.
  10. Credentials of key personnel, particularly the Production Manager.
  11. Detailed flowchart of your factory’s water production process showing water source, treatment process and production steps.
  12. A list of all equipment, suppliers name and contact details.
  13. Geological survey of borehole where applicable showing terrain characteristic, depth of drill etc.
  14. Copies of detailed labels for intended bottle or sachet water products based on the trademark registered. The labels should show the name of product, full address/contact of factory, volume capacity, batch number, date of manufacture, expiration date and logo.

Copies of these documents together with the CAC certificate, proof of Trademark registration and respective evidence of statutory fee payment to NAFDAC (for production inspection of factory and laboratory analyses of produced water samples after inspection) are filed and submitted with the application for production inspection to the designated NAFDAC office in your state of residence.

Stage B.           PRODUCTION INSPECTION BY NAFDAC INSPECTORS

Once you’ve submitted all the required documents to NAFDAC and they find no discrepancies or mistakes, a date is fixed for Production Inspection and you’ll get notified about it.

On the appointed date, be ready with your original documents and four copies of same documents for the inspectors and your production manager. Your production staff should be well acquainted with the respective SOPs and your water factory should be in prepared condition. The Production Manager is the main representative on this day as he/she will be the person to take the inspectors around and answer most of the questions especially the technical aspects. NAFDAC inspectors are generally friendly, but since they have a duty to safeguard public health and maintain strict standards, they might come out sounding harsh during their assessments and questioning.

They will verify the authenticity of the documents you filed by going through the original copies you’d made available. Then inspect your interior and labelled room areas for proper furnishing, fittings and equipping, your exterior surroundings, borehole and distance to septic tank, raw water source, water tanks and treatment plants, production equipment, production processes and SOPs.

If your facility and processes meets NAFDAC specifications, samples of your raw water, produced bottle water and sachet water are taken for analyses in NAFDAC’s laboratories. If the samples gotten from your bottle/sachet water factory pass NAFDAC laboratory tests, they’ll issue you a notification and you can expect your number within two months.

Whereby there are observed discrepancies in your facility, installations or production process, a Compliance Directive (CD) will be issued to you listing all the observed items that do not meet regulations and remedial action expected to be carried out. You are expected to resolve all issues listed in the CD and respond via a letter notifying NAFDAC about your actions as well as write an application for Re-inspection (with attendant payment of Production Re-inspection fees).

If your facility satisfies all requirements after re-inspection, samples of your raw water and treated water produced in the respective packs are then taken for laboratory analyses. In the event that the water samples,  particularly the packaged treated water fails the NAFDAC laboratory tests, you will get notified and you’d have to troubleshoot the water treatment process in your facility, identify where the problem comes from (after another laboratory test by your IPAN laboratory partner) and fix your treatment process to satisfy all regulatory requirements. Until your water production facility meets all NAFDAC requirements, they will not issue you a number and you cannot produce for public consumption.

After you get your NAFDAC number and have started production, you must maintain required production standards at all times because occasionally, NAFDAC inspectors will come around unannounced to check on your water producing facility, and they will not hesitate to enforce disciplinary actions if your standards fall below regulations.

The above outline processes are a summary of the basic steps to get NAFDAC number for your factory produced bottle/sachet water in Nigeria.

Check out samples of cleaning and sanitation standard operating procedures (SOP) for sachet water production and packaging factories

[Cleaning SOP]