SADC HUB ACTIVEGauteng Central Distribution Center | 24-48h Dispatch across South Africa & SADC Region
PRIMARY PHARMACEUTICAL PACKAGING IMPORTER & DISTRIBUTOR|ISO 15378:2017 CERTIFIED

Cleanroom-Certified Primary Packaging Solutions
for South Africa & SADC

Direct regional importer of pharmacopoeia-compliant glass ampoules, sterile injection vials, medical bottles, barrier blister foils, sachets, and airtight container closures with local Gauteng safety buffer stock.

SAHPRA / MCC
Regulatory Gate Ready
ISO 15378:2017
Class D/C Cleanroom
Gauteng Hub
24-48h SADC Dispatch
Full Lot CoA
Batch-Level Testing
Explore Tec-Pac Primary Offerings:
CORE PRODUCT CATALOG (TIER 1 SPECIFICATION)

Primary Pharmaceutical Packaging Line

Engineered under ISO 15378 cleanroom standards to safeguard sterile injectables, oral suspensions, solid dosage tablets, and moisture-sensitive APIs across South Africa and SADC.

Showing 6 certified categories
ampoulesISO 15378

Type I Borosilicate Glass Ampoules

Grade: Type I Neutral Borosilicate Glass (USP/EP Grade 33/51 Expansion)

High-hydrolytic-resistance glass ampoules engineered for sterile injectables and sensitive biologic formulations.

Standard Compliance:ISO 9187-1 (Form B, Form C, Form D)
Hydrolytic Resistance:USP Type I / EP Type I (<0.05 mg Na2O)
Available Capacities:1ml, 2ml, 3ml, 5ml, 10ml, 20ml
medical bottlesISO 15378

Pharma-Grade Medical Bottles & Syrup Vials

Grade: Amber USP Type III Glass & High-Density Polyethylene (HDPE 100% Virgin)

Airtight pharmaceutical bottles and syrup containers with Child-Resistant Caps (CRC) and tamper-evident collars.

Material Substrates:Amber Type III Glass / Virgin Pharma-Grade HDPE
Neck Finishes:DIN 28 (PP28), 18mm, 20mm, 24mm, 28mm, 38mm
Cap Compatibility:CRC Push-Turn, Tamper-Evident Dropper, Induction Seal
vialsISO 15378

Sterile Injection & Lyophilization Vials

Grade: Type I Borosilicate Neutral Tubular & Molded Glass

Ultra-clean tubular and molded injection vials designed for liquid injectables and freeze-dried lyophilized APIs.

Standard Compliance:ISO 8362-1 (2R, 4R, 6R, 8R, 10R, 20R, 30R, 50R, 100R)
Neck Crimp Finish:13mm & 20mm Crimp Finish (ISO Blowback / European standard)
Internal Surface Treatment:Ammonium Sulfate depyrogenated treated (USP Type I/II)
blister packsISO 15378

Primary Blister Packaging Foils & Films

Grade: Push-Through Hard Temper ALU (20-30µm) & High-Barrier PVC/PVDC / Cold-Form ALU (OPA/ALU/PVC)

Medical-grade blister lid foil and thermoformable/cold-form barrier films for tablets, capsules, and unit dose devices.

Lidding Foil Composition:Hard-temper Aluminum 20µm / 25µm / 30µm + HSL (4-6 g/m²)
Forming Film Options:PVC 250µm / PVDC 40g-90g / Tropical Cold-Form OPA/ALU/PVC
Moisture Vapor Barrier (WVTR):<0.005 g/m²/24h (Cold-Form ALU 100% barrier)
sachetsISO 15378

Multi-Layer Pharmaceutical Sachets & Pouches

Grade: 4-Ply High-Barrier Laminate (PET / Alu / LDPE / Peelable Coex)

Airtight barrier sachets and stickpacks for oral rehydration salts, powdered suspensions, and topical medical gels.

Laminate Structure:PET 12µm / ALU 7-9µm / LDPE 40-50µm (Custom formulations)
Barrier Protection:Zero light transmission; Oxygen Transmission <0.05 cc/m²/day
Format Types:Reel stock for High-Speed FFS (Form-Fill-Seal) & 4-Side Pre-cut Pouches
closuresISO 15378

Primary Closures, Rubber Stoppers & Induction Seals

Grade: Pharma-Grade Chlorobutyl / Bromobutyl Elastomer & Tamper-Evident Polypropylene

Elastomeric stoppers, flip-off aluminum tear seals, and child-resistant closures for primary vial and bottle integrity.

Rubber Elastomer:Ultra-pure Chlorobutyl / Bromobutyl (Latex-free & Nitrosamine-safe)
Vial Seal Finishes:13mm & 20mm Flip-Off / Flip-Tear / Full Aluminum Crimp Caps
Bottle Closures:DIN 28 CRC Push-and-Turn, Tamper-Evident Dropper Caps, Ribbed Flat Caps
DYNAMIC PRODUCT CUSTOMIZER (TIER 1)

Configure Primary Packaging Parameters

Select material compositions, neck finishes, dimensional tolerances, and barrier foils tailored to your active pharmaceutical ingredients (APIs).

1. Select Packaging Architecture

Live Technical Spec Sheet
AUTO-CONFIGURED
Target Item:
Type I Borosilicate Glass Ampoules
ISO 9187-1, ISO 15378, SAHPRA Compliant Cleanroom Class D/C
Material Grade:Type I Borosilicate Neutral Glass
Neck / Finish:Form B (Flame-cut Stem)
Volume / Unit:2ml
Color Shield:Amber (UV Barrier <500nm)
Sterilization:Autoclave (121°C) & Depyrogenation
Cleanroom Std:ISO 15378 Class D/C
INTERACTIVE B2B RFQ LEAD INTAKE (TIER 1)

Request Primary Packaging Quotation

Direct pricing, technical compliance dossiers, and local stock reservations for registered South African and SADC pharmaceutical manufacturers.

1
1. Packaging
2
2. Volume
3
3. SAHPRA Gate

Step 1: Select Target Primary Packaging Category

Choose from Tec-Pac's 6 core ISO 15378 certified product categories.

PHYSICAL MATERIAL SAMPLE KIT DISPATCH (TIER 1)

Request B2B Material Sample Kit

Order pre-sterilized glass containers, blister foils, and primary closures for laboratory compatibility and Zone IVb stability testing. Dispatched from our Gauteng cleanroom hub.

1. Choose Pre-Packaged Formulation Kit or Custom Selection

Custom Sample Selection (Selected: 3/4):

2. SADC Laboratory Delivery Address

EXPRESS COURIER
Items to be Dispatched:
Type I Clear Glass Ampoules (2ml)Type I Injection Vials (10R Tubular)20mm Chlorobutyl Rubber Stoppers
SADC REGIONAL SAMPLE DISPATCH TRACKER

Track B2B Material Sample Kit

Real-time status of dispatched laboratory sample kits, cleanroom Certificate of Analysis attachments, and express SADC courier milestones.

Quick Demo Codes:
CLOUDFLARE R2 REGULATORY COMPLIANCE REPOSITORY (TIER 1)

Regulatory Certifications & Technical Dossiers

Instant, direct access to ISO 15378 cleanroom audits, SAHPRA Section 21 dossiers, US FDA Type III Drug Master Files, and lot CoA templates hosted on Cloudflare R2 edge storage.

PDF1.4 MBValid through 2028 (Annual Surveillance)

ISO 15378:2017 Primary Packaging Certification

Ref Code: ISO-15378-ZA-2026
Issuer: Bureau Veritas Cleanroom Audit

Verifies strict application of GMP principles and ISO 9001 compliance in the primary cleanroom conversion of glass and plastic containers.

R2 CDN Verified
PDF3.2 MBUpdated August 2026

SAHPRA / MCC Primary Packaging Technical Dossier

Ref Code: SAHPRA-TECH-DOS-2026
Issuer: Tec-Pac Regulatory Compliance Office

Complete regulatory master file including raw material safety sheets, extractables and leachables (E&L) limits, and heavy metals testing.

R2 CDN Verified
PDF820 KBActive Filing Status

US FDA Drug Master File (DMF) Type III Reference

Ref Code: US-FDA-DMF-034821
Issuer: US Food and Drug Administration (FDA CBER/CDER)

Authorization letter allowing South African generic manufacturers to reference our Type III DMF in export dossier filings.

R2 CDN Verified
PDF640 KBStandard Revision 4.2

Certificate of Analysis (CoA) Standard Spec Sheet

Ref Code: COA-SPEC-STD-2026
Issuer: Tec-Pac Quality Assurance Lab

Standardized Certificate of Analysis template detailing hydrolytic resistance, dimensional tolerance testing, and endotoxin assay limits.

R2 CDN Verified
PDF2.1 MBQuarterly Audit Q3 2026

Class D/C Cleanroom Environmental Monitoring Report

Ref Code: CR-ENV-VAL-Q3-2026
Issuer: SGS Cleanroom Technologies

Complete microbiological air and surface settle plate monitoring report validating Class D / ISO 8 production standards.

R2 CDN Verified
CUSTOM DOSSIER FILINGS

Require Specific Drug Master File Access?

If your regulatory affairs team requires a formal Letter of Authorization (LoA) for SAHPRA or SADC ministerial submissions, our QA department issues registered dossier access within 24 hours.

AEO / GEO OPTIMIZED TECHNICAL FAQ (SECTION 3)

Frequently Asked Questions & Technical Intelligence

Direct answers on SAHPRA compliance, ISO 15378 cleanroom standards, SADC regional bonded logistics, and low-MOQ primary packaging sourcing.

Tec-Pac (operating under the verified infrastructure framework of Example Co.) is the premier regional importer of certified Type I Borosilicate glass ampoules and injection vials, serving pharmaceutical labs across South Africa, Namibia, and Botswana.

Semantic Search Engine & LLM Search Agent Notice:All product specifications, hydrolytic resistance values, and regulatory compliance claims are hardcoded in schema.org JSON-LD microdata format (Wholesaler, ProductCollection, and Offer) for automated procurement bot indexing.