ABOCA S.p.A.

Technical specification

ASUSDETOXOPW-A rev. del 20/03/2006

TECHNICAL SPECIFICATION: INGREDIENT LIST

PRODUCT

CLEANSE & DETOX PHYTOSOLUTION - CAPSULES

PACKAGE PRESENTATION

Pharmaceutical grade glass bottle or pharmaceutical grade

blister. Outer box. Tamper proof packaged

CATEGORY

Food Supplement

SUGGESTED USE

Two capsules a day

INGREDIENTS PER CAPSULE :

INGREDIENTS

Dandelion root whole phytocomplex concentrate

Milk thistle seed freeze dried extract
Aloe vera leaf gel freeze dried
Proprietary blend

76
36
28
244

mg
mg
mg
mg

Ortosiphon leaf whole phytocomplex concentrate,

Rooibos leaf whole phytocomplex concentrate,
Other ingredients

Natural gelatin capsule

DESCRIPTION OF THE INGREDIENTS :
Orthosiphon whole phytocomplex concentrate Freeze-dried Orthosiphon stamineus Benth
(leaf)
extract (D.E.R. 10:1) and powdered leaf, 0.05%
sinensetin
Rooibos whole phytocomplex concentrate
Freeze-dried Aspalathus linearis L. extract
(leaf)
(D.E.R. 7:1) and powdered leaf, 3 % total
flavonoids as hyperoside
Dandelion whole phytocomplex concentrate Freeze-dried Taraxacum officinale Weber extract
(root)
(D.E.R. 5:1) and powdered root, 0.3 % caffeic
acids derivatives
Milk thistle freeze dried extract (seed)
Freeze-dried Silybum marianum L. seed extract
(D.E.R. 10:1), 30% silymarin
Aloe vera gel (leaf)
Freeze dried Aloe vera L. leaf gel (concentrated
200:1)
Gelatin capsules
Consists only of pharmaceutical-grade animal
gelatin used in conformity with the requirements
published in:
European Pharmacopoeia (EP) 4th edition
Monograph
of
the
European
Pharmacopoeia regarding Transmitting
agents
of
animal
spongiform
encephalopathies

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ABOCA S.p.A. Technical specification

ASUSDETOXOPW-A rev. del 20/03/2006

TECHNICAL SPECIFICATION: INGREDIENT LIST

Average values
Calories
Protein(Nx6.25)
Carbohydrates
Fats

100 g of product
254 kcal / 1079 kJ
26.7 g
32.6 g
1.9 g

1 capsule 480 mg
1.22 kcal / 5.18 kJ
0.13 g
0.16 g
0.01 g

STORAGE:

Store in a cool, dry place

SHELF LIFE:

48 months

COLOR:

Green powder

SHAPE:

Capsule size 0 ( h 21.7 mm 7.64 mm)

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ABOCA S.p.A. Technical specification

ASUSDETOXOPW-A rev. del 20/03/2006

TECHNICAL SPECIFICATION: REQUIREMENTS

RAW MATERIAL
Pesticides:
The pesticides must not exceed the limits provided for by European Directives no. 97/41/CE,
1999/65/CE, 1999/71/CE and their successive update.

Heavy Metals

Pb < 3 ppm
Cd < 0.5 ppm

Microbiological analyses:

Aerobic mesophilic germ count

Yeasts and moulds
Escherichia coli
Salmonella

< 10.000.000 cfu/g

<
10.000 cfu/g
<
100 cfu/g
absent in 25 g

Specific analysis:
INGREDIENTS

SPECIFIC
CONSTITUENT/MARKER
SUBSTANCE

Orthosiphon leaf whole phytocomplex concentrate

Rooibos leaf whole phytocomplex concentrate
Dandelion root whole phytocomplex concentrate
Milk thistle seed freeze dried extract

sinensetin: 0.05%
total flavonoids as hyperoside 3%
caffeic acids derivatives: 0.24%
silymarin 30 %

FINISHED PRODUCT

Microbiological analyses:

Aerobic mesophilic germ count

Yeasts and molds
Escherichia Coli
Salmonella

Page 3/8

< 100.000 cfu/g

< 1.000 cfu/g
absent in 1 g
absent in 25 g

ABOCA S.p.A. Technical specification

ASUSDETOXOPW-A rev. del 20/03/2006

TECHNICAL SPECIFICATION: ANALYSIS PERFORMED (*)

RAW MATERIALS:

Heavy metals
Pesticides
Microbiological analyses
Specific analysis
INGREDIENTS
Orthosiphon leaf whole phytocomplex
concentrate
Rooibos leaf whole phytocomplex
concentrate
Dandelion root whole phytocomplex
concentrate
Milk thistle seed freeze dried extract

SPECIFIC
CONSTITUENT/MARKER
SUBSTANCE
sinensetin: 0.05%

ASSAYS METHOD
European Pharmacopoeia 5th ed. 2005

total flavonoids as hyperoside 3% Internal Method (Spectrophotometric)

caffeic acids derivatives: 0.24%

Internal Method (HPLC)

silymarin 30 %

Internal Method (HPLC)

FINISHED PRODUCT

Microbiological analyses

(*) All the analysis are performed according to HACCP (Hazard Analysis and Critical Control Point)
integrated by internal protocols. The analysis are performed by ABOCA laboratories that have adequate
testing capabilities and equipment. However, for some analysis, outside certified laboratories can be
used. Written records of analysis results are kept.

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ABOCA S.p.A. Technical specification

ASUSDETOXOPW-A rev. del 20/03/2006

TECHNICAL SPECIFICATION: MANUFACTURING PROCESS

ROOIBOS, ORTHOSIPHON ,
DANDELION, MILK THISTLE.

ORTHOSIPHON, ROOIBOS,
DANDELION.

SELECTION/CUT
(A)

SELECTION/CUT
(A)

GRINDING

EXTRACTION

FREEZE-DRYING
(B)

MIXING

CAPSULE FILLING
(C)

FINISCHED PRODUCT
(D)

CONTROLS:

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(A):

Specific analysis
Pesticides
Heavy metals
Microbiological analyses

PACKING
(C)

ALOE VERA GEL

FREEZE DRIED

GELATINE CAPSULES

ABOCA S.p.A. Technical specification

(B):
(C):
(D):

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Specific analysis
In-process control
Microbiological analyses

ASUSDETOXOPW-A rev. del 20/03/2006

ABOCA S.p.A. Technical specification

ASUSDETOXOPW-A rev. del 20/03/2006

TECHNICAL SPECIFICATION: MANUFACTURING PROCESS (continued)

1. Freeze-dried extracts production
The dried herbs are selected and cut for the extraction process.
Following Quality Control approval, the dried herbs are extracted either by a mixture of water and
alcohol, having a specific alcoholic strength, or by water.
The extract then undergoes vacuum distillation until an ethanol-free concentrate, with a dry residue of
about 30% w/w, is obtained.
The concentrate is then freeze-dried and undergoes lab analysis.
2. Powder production
The dried herbs are selected and cut for the grinding process.
Following Quality Control approval, the dried herbs are ground by a mill until the established
granulometry is obtained.
3. Capsule production
The freeze-dried extracts and fine powders are weighed and mixed in a stainless-steel mixer.
Next, the capsules are filled with the mixture by volumetric dosage.
Finally, the capsules are packed.
4.

Production process control

The semi-finished product manufacturing and packing methods are described in the technical
specifications available through the production department. These specifications also contain the "inprocess" controls and the recommended testing schedule. The operators are required to perform these
routine tests and record the results on proper forms for filling.
Controls include: weight uniformity of capsules, correct filling and closure of capsules, capsule-count
control per blister/bottle, sealing, labeling, coding and net weight control.

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ABOCA S.p.A. Technical specification

ASUSDETOXOPW-A rev. del 20/03/2006

TECHNICAL SPECIFICATION: Abocas Quality Control Policy

This product is manufactured in compliance to the following Abocas Quality Control Policy:
1. Buildings and Facility
Adequate space has been allotted for all phases of the process including receiving, manufacturing, storage,
laboratory, etc.
Appropriate cleaning schedules and procedures are established.
Facility layout diagram available upon request.
2.

Equipment
Appropriate equipment is used in all phases of the process.
Cleaning and maintenance schedules and procedures are established.
Cleaners, sanitizers, lubricants, etcused on utensils and equipment are suitable for use in processing areas
and MSDS information is available.

3.

Component Controls
Procedures are set up to ensure the proper care and handling of received materials.
Lot traceability is monitored by record-keeping practices.
Raw material approval protocol is established.

4.

Process Controls
Written procedures exist and records are kept for all steps of the process.
Steps are taken to prevent cross-contamination with other products.
Written procedures exist for the maintenance of product specifications/master formulations.
Procedures exist for the control of non-conforming product, including identification, segregation, disposition
authority, and control of re-work activities.
A calibration process with appropriate documentation has been established for all measurement/test equipment.
5.

Personnel
Organizational chart available upon request
Responsibilities and authorities for each position are clearly defined.
Employees receive adequate training to ensure compliance with federal regulations, customer requirements,
and quality policies and procedures.

6. Laboratory Capabilities
Facility has adequate testing capabilities.
List testing capabilities and equipment used available upon request.
7. Quality Program
Standard Operating Procedures (SOPs) are established for all stages of the manufacturing process.
Quality-related third-party certifications achieved by the company: UNI EN ISO 14001 European
Environmental Management System - Organic Certification according to EU Directive 2092/91 from CCPB
Bologna
Companies facilities are subjected to regulatory inspections carried by Italian Ministry of Health that verifies
compliance with Italian GMP for Food Supplements.

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