Asept Pak

What Asept Pak does

Asept Pak, Inc. is a privately held contract manufacturer based in Malone, New York, specializing in Blow-Fill-Seal (BFS) sterile packaging of medical devices and pharmaceutical liquids. The company operates an 18,000 square foot FDA-registered, ISO 13485:2016-certified, cGMP-compliant manufacturing facility equipped with Rommelag BFS machines capable of producing containers ranging from 0.25mL to 1 liter in unit-dose or multi-dose formats. Its product portfolio spans sterile Water for Injection USP, sterile saline, ophthalmic drops, inhalation solutions, wound care products, purified water USP, sucrose for neonates, lab test reagents, eyewash solutions, and intranasal, oral, and topical liquid formulations. The company also offers custom container and closure design services, including luer lock, luer-slip, twist-off, and metered drop features.

Asept Pak generates revenue through professional services contract manufacturing engagements, with project-specific quoting rather than published pricing. Its go-to-market model is sales-led and direct, centered on Executive Officer Dr. Gary Hanley engaging healthcare providers, medical device companies, and pharmaceutical firms via phone and email. In addition to traditional contract manufacturing, the company provides new product development support spanning formulation development, scale-up, stability studies, and analytical services through commercialization. The single-process nature of BFS technology, which forms, fills, and seals containers in one continuous sterile operation, provides the company's primary value proposition around reduced contamination risk, lower per-unit cost, and operational efficiency versus conventional sterile-fill techniques.

The company's competitive position rests on its regulatory credentials (FDA registration, ISO 13485:2016, cGMP), accumulated process expertise with Rommelag BFS equipment, and a management team with over 75 years of combined pharmaceutical R&D and manufacturing experience. Asept Pak operates as a small, privately held boutique CDMO with no disclosed funding rounds, no public revenue data, no M&A activity, and a single U.S. facility in Malone, NY.

Name

Asept Pak

Legal name

Asept Pak, Inc.

Website

https://aseptpak.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Short description

Asept Pak is a privately held Blow-Fill-Seal contract manufacturer in Malone, New York, providing cGMP-compliant sterile packaging of medical devices and pharmaceutical liquids for healthcare providers, medical device companies, and pharmaceutical firms.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Drug Product Fill-Finish & Aseptic Manufacturing Services (HLAAAKAB)

akta.pro secondary industries

Aseptic Processing, Fill-Finish & Sterile Manufacturing Tech (isolators, lyophilization interfaces) (HLAAAJAG), Sterile & Aseptic Medical Packaging (Pouches, Wraps, Sterile Barriers) (IMALAIAB)

Keywords

• Blow-fill-seal manufacturing
• Sterile contract manufacturing
• Aseptic packaging services
• Pharmaceutical fill-finish
• Medical device packaging

Headquarters

HQ city

Malone

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Supply Chain, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Manufacturing Services: Asept Pak provides contract manufacturing services for Blow-Fill-Seal sterile packaging of medical device products. They offer both traditional contract manufacturing and new product development support including formulation development, scale-up, stability, and analytical support through commercialization.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Asept Pak is a cGMP-compliant Blow-Fill-Seal (BFS) contract manufacturer that produces sterile liquid medical device and pharmaceutical products in a single automated closed-system process. The company uses Rommelag BFS machines to extrude pharmaceutical-grade resin, blow-form containers, fill them via mandrel, and seal them under sterile conditions, with fill volumes ranging from 0.25 mL to 1 liter. In addition to contract manufacturing, Asept Pak offers custom container/closure design services and new product development support from formulation through commercialization.

Product overview

Asept Pak provides Blow-Fill-Seal (BFS) contract manufacturing services for the healthcare and pharmaceutical industries, operating FDA-registered, ISO 13485:2016-certified facilities. Their core offering is BFS technology using Rommelag machines that form, fill, and seal sterile containers in a single automated process. The product portfolio spans sterile pharmaceutical waters (Sterile WFI USP, Purified Water USP), sterile saline solutions, ophthalmic drops, inhalation solutions, wound care products, lab test reagents, eyewash solutions, sucrose for neonates, intranasal products, and oral/topical liquids. Fill volumes range from 0.25mL to 1 liter in unit-dose or multi-dose formats. Beyond manufacturing, Asept Pak offers custom container design services including specialized closures (luer lock, luer-slip, twist-off, metered drops) and comprehensive new product development support from formulation through commercialization.

Differentiator

Problem solved

Functional benefit

Products and services

• Blow-Fill-Seal Contract Manufacturing Services cGMP-compliant Blow-Fill-Seal contract manufacturing service that forms, fills, and seals sterile containers in a single closed automated process for medical device and pharmaceutical customers. Designed for healthcare providers, medical device companies, and pharmaceutical firms requiring aseptic packaging.
• Custom Container and Closure Design Services Custom container and closure design and tooling development, including luer lock, luer-slip, twist-off caps, and metered drop configurations, for BFS-packaged medical device and pharmaceutical products.
• New Product Development Support Services Technical services supporting new product development, including formulation development, scale-up, stability studies, and analytical support, from development through commercialization for pharmaceutical and medical device products.
• Sterile WFI USP (Water for Injection) Manufacturing Contract-manufactured Sterile Water for Injection USP packaged in BFS containers for pharmaceutical and medical device applications.
• Sterile Saline Solutions Manufacturing Sterile saline solutions contract-manufactured and packaged using Blow-Fill-Seal technology for medical and pharmaceutical use.
• Ophthalmic Drops Manufacturing Sterile ophthalmic eye drops packaged in unit-dose or multi-dose BFS containers with flexible design options including luer lock and metered drop caps.
• Inhalation Solutions Manufacturing Sterile inhalation solutions contract-manufactured using Blow-Fill-Seal technology for respiratory therapy applications.
• Wound Care Products Manufacturing Sterile wound care liquid products packaged using Blow-Fill-Seal technology for aseptic delivery.
• Purified Water USP Manufacturing Purified Water USP contract-manufactured and packaged via Blow-Fill-Seal for pharmaceutical and medical device manufacturing applications.
• Sucrose for Neonates Manufacturing Specialized sucrose formulation packaged in sterile unit-dose BFS containers for neonatal care applications.
• Lab Test Reagents Manufacturing Sterile laboratory test reagent solutions contract-manufactured and packaged via Blow-Fill-Seal technology.
• Eyewash Solutions Manufacturing Sterile eyewash liquid products contract-manufactured using Blow-Fill-Seal technology.
• Intranasal Products Manufacturing Intranasal liquid pharmaceutical products contract-manufactured and aseptically packaged via Blow-Fill-Seal.
• Oral Liquids Manufacturing Sterile oral liquid pharmaceutical formulations contract-manufactured and packaged using Blow-Fill-Seal technology.
• Topical Liquids (Creams, Gels, Ointments) Manufacturing Topical liquid pharmaceutical products including creams, gels, and ointments contract-manufactured under sterile conditions via Blow-Fill-Seal.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators3 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Unither Pharmaceuticals: Unither is one of the largest dedicated Blow-Fill-Seal CDMOs globally, with sterile unit-dose manufacturing across multiple sites. It competes head-to-head with Asept Pak for pharma, ophthalmic, and respiratory BFS contract manufacturing work.
• Weiler Engineering: Weiler Engineering is a US-based aseptic processing and Blow-Fill-Seal equipment manufacturer and contract manufacturer. It is one of the closest direct comparables to Asept Pak's BFS contract manufacturing model.
• Rommelag (Rommelag CMO): Rommelag invented Blow-Fill-Seal and supplies the very machines Asept Pak uses; its CMO division (Rommelag CMO) competes directly as a BFS contract manufacturer for sterile liquids and pharmaceuticals.
• Aphena Pharma Solutions: Aphena is a US-based contract manufacturer offering sterile and non-sterile liquid fill-finish including Blow-Fill-Seal. It competes with Asept Pak for similar small-to-mid pharma and medical device customers.

Broad incumbents

• Catalent: Catalent is a large global CDMO with significant aseptic fill-finish capacity including Blow-Fill-Seal. It competes with Asept Pak on sterile liquid and ophthalmic BFS work but as part of a much broader delivery portfolio.
• Recipharm: Recipharm is a European-headquartered CDMO with sterile liquid fill-finish capabilities. It serves many of the same pharma customers as Asept Pak, offering broader scale and geographic reach.
• Stevanato Group: Stevanato Group manufactures glass and plastic primary packaging and provides integrated fill-finish services for injectables. It competes with Asept Pak for sterile liquid packaging contracts and represents the broader plastics/glass packaging substitute.
• Gerresheimer: Gerresheimer is a global primary packaging manufacturer for pharma including glass and plastic vials/bottles. It overlaps with Asept Pak on sterile container supply and competes for the same ophthalmic and injectable pharma customers.
• Becton, Dickinson and Company (BD): BD is a global medical device and pharmaceutical systems company with significant BFS-based manufacturing for pre-filled syringes, ophthalmics, and injectables. It competes with Asept Pak across multiple product categories including ophthalmic and inhalation liquids.

Regional players

• SIFI S.p.A. SIFI is an Italian ophthalmic pharmaceutical company with its own BFS manufacturing capabilities, focusing on ophthalmic drops. It is comparable in product format but competes primarily in European markets rather than with Asept Pak's US customer base.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/asept-pak-inc.

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Asept Pak